Ignite Creation Date:
2025-12-25 @ 1:37 AM
Ignite Modification Date:
2025-12-25 @ 11:53 PM
Study NCT ID:
NCT04774094
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2021-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Ceftazidime-Avibactam (CAZ-AVI) in Chinese Participants With HAP (Including VAP)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077299', 'term': 'Healthcare-Associated Pneumonia'}], 'ancestors': [{'id': 'D003428', 'term': 'Cross Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000595613', 'term': 'avibactam, ceftazidime drug combination'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquires@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day 1 up to 32 days after last dose of CAZ-AVI (maximum up to 46 days; maximum treatment duration was of 14 days)', 'description': 'Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Non-SAES are reported at 5% threshold.', 'eventGroups': [{'id': 'EG000', 'title': 'CAZ-AVI', 'description': 'Participants received CAZ-AVI (Zavicefta), 2.5 g (ceftazidime 2g + avibactam 0.5g), IV as 2 hours infusion every 8 hours for a minimum of 7 days and a maximum of 14 days. Participants were followed up to maximum of 32 days after the last dose of study intervention.', 'otherNumAtRisk': 235, 'deathsNumAtRisk': 235, 'otherNumAffected': 43, 'seriousNumAtRisk': 235, 'deathsNumAffected': 17, 'seriousNumAffected': 35}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 27}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}], 'seriousEvents': [{'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Sudden cardiac death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Anti-neutrophil cytoplasmic antibody positive vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Fungaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Intracranial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Pneumonia fungal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Puncture site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Brain herniation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Wound haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Hypoxic-ischaemic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Subdural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Asphyxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Clinical Cure at Test of Cure (TOC) Visit: Clinical Modified Intent-to-Treat (cMITT) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CAZ-AVI', 'description': 'Participants with HAP received CAZ-AVI, 2.5 g, IV as 2 hours infusion every 8 hours for a maximum of 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '62.7', 'groupId': 'OG000', 'lowerLimit': '56.0', 'upperLimit': '69.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'TOC visit: any day from Day 21 to 25', 'description': 'Clinical cure: participants were considered to be a success for clinical response at TOC visit if the participants were not a clinical failure at end of treatment (EOT), and the participants were alive and all signs and symptoms of pneumonia were resolved or improved to an extent that no antibacterial therapy for HAP was taken between EOT and TOC inclusive. Gram negative is abbreviated as gram -ve and gram positive as gram +ve.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'cMITT: MITT subset and participants whose baseline respiratory or blood culture showed gram -ve pathogens with or without concomitant gram +ve pathogens (excluding those with gram -ve pathogens unexpected to respond to either study drug \\[participants with only monomicrobial gram -ve infection: any Acinetobacter species/ Legionella species/ Stenotrophomonas maltophilia/ Elizabethkingia meningoseptica\\]) or in whom no etiologic pathogens identified from respiratory or blood culture at baseline.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinical Cure at EOT Visit: cMITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CAZ-AVI', 'description': 'Participants with HAP received CAZ-AVI, 2.5 g, IV as 2 hours infusion every 8 hours for a maximum of 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '75.1', 'groupId': 'OG000', 'lowerLimit': '68.9', 'upperLimit': '80.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'EOT visit: within 24 hours after the completion of the last infusion of study intervention (study treatment was a minimum of 7 days and maximum of 14 days)', 'description': 'Clinical cure: participants were considered to be a success for clinical response at EOT visit if the participants were alive and all signs and symptoms of pneumonia were resolved or improved such that all antibacterial therapies for HAP/ VAP were stopped. No antibacterial therapy other than those outlined by the protocol was administered for HAP prior to EOT.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'cMITT: MITT subset and participants whose baseline respiratory or blood culture showed gram -ve pathogens with or without concomitant gram +ve pathogens (excluding those with gram -ve pathogens unexpected to respond to either study drug \\[participants with only monomicrobial gram -ve infection: any Acinetobacter species/ Legionella species/ Stenotrophomonas maltophilia/ Elizabethkingia meningoseptica\\]) or in whom no etiologic pathogens identified from respiratory or blood culture at baseline.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinical Cure at EOT and TOC Visit: Microbiological Modified Intent-to-Treat (mMITT) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CAZ-AVI', 'description': 'Participants with HAP received CAZ-AVI, 2.5 g, IV as 2 hours infusion every 8 hours for a maximum of 14 days.'}], 'classes': [{'title': 'EOT visit', 'categories': [{'measurements': [{'value': '70.0', 'groupId': 'OG000', 'lowerLimit': '59.4', 'upperLimit': '79.2'}]}]}, {'title': 'TOC visit', 'categories': [{'measurements': [{'value': '57.5', 'groupId': 'OG000', 'lowerLimit': '46.6', 'upperLimit': '67.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'EOT visit: within 24 hours after the completion of the last infusion of study intervention (study treatment was a minimum of 7 days and maximum of 14 days); TOC visit: any day from Day 21 to 25', 'description': 'Clinical cure at EOT: participants were considered to be a success for clinical response at EOT visit if the participants were alive and all signs and symptoms of pneumonia were resolved or improved such that all antibacterial therapies for HAP/VAP were stopped. No antibacterial therapy other than those outlined by the protocol was administered for HAP prior to EOT. Clinical cure at TOC: participants were considered to be a success for clinical response at TOC visit if the participants were not a clinical failure at EOT, and the participants were alive and all signs and symptoms of pneumonia were resolved or improved to an extent that no antibacterial therapy for HAP was taken between EOT and TOC inclusive.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "mMITT:MITT subset and participants with proper respiratory culture (RC) showing gram-ve pathogens,excluding participants unexpected to respond to CAZ-AVI (participants with only monomicrobial gram-ve infections:any Acinetobacter species/Legionella species/Stenotrophomonas maltophilia/Elizabethkingia meningoseptica).If baseline RC unavailable or didn't identify respiratory pathogen, but gram-ve organism causing pneumonia was identified from baseline blood cultures,participant qualified for mMITT."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Favorable Per-Participant Microbiological Response at the EOT and TOC Visits: mMITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CAZ-AVI', 'description': 'Participants with HAP received CAZ-AVI, 2.5 g, IV as 2 hours infusion every 8 hours for a maximum of 14 days.'}], 'classes': [{'title': 'EOT visit', 'categories': [{'measurements': [{'value': '77.5', 'groupId': 'OG000', 'lowerLimit': '67.5', 'upperLimit': '85.6'}]}]}, {'title': 'TOC visit', 'categories': [{'measurements': [{'value': '51.3', 'groupId': 'OG000', 'lowerLimit': '40.4', 'upperLimit': '62.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'EOT visit: within 24 hours after the completion of the last infusion of study intervention (study treatment was a minimum of 7 days and maximum of 14 days); TOC visit: any day from Day 21 to 25', 'description': 'For participants from whom only 1 causative pathogen is isolated, the overall microbiological response assessment was based on the microbiological response assessment for that pathogen. For participants from whom more than 1 baseline pathogen was isolated, the overall microbiological response assessment was "favorable" only if the microbiological response assessment for each of the baseline pathogens isolated was "favorable". Favorable microbiological response included eradication (an adequate source specimen demonstrated absence of the original baseline pathogen) and presumed eradication (an adequate source specimen was not available to culture and the participant was assessed as a clinical cure). In this outcome measure percentage of participants with favorable per-participant microbiological response are recorded.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "mMITT:MITT subset and participants with proper RC showing gram-ve pathogens,excluding participants unexpected to respond to CAZ-AVI (participants with only monomicrobial gram-ve infections:any Acinetobacter species/Legionella species/Stenotrophomonas maltophilia/Elizabethkingia meningoseptica).If baseline RC unavailable or didn't identify respiratory pathogen, but gram-ve organism causing pneumonia was identified from baseline blood cultures,participant qualified for mMITT."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Favorable Per-Pathogen Microbiological Response at the EOT and TOC Visits: mMITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CAZ-AVI', 'description': 'Participants with HAP received CAZ-AVI, 2.5 g, IV as 2 hours infusion every 8 hours for a maximum of 14 days.'}], 'classes': [{'title': 'EOT visit: Enterobacter cloacae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000', 'lowerLimit': '3.9', 'upperLimit': '82.3'}]}]}, {'title': 'EOT visit: Escherichia coli', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '62.1', 'upperLimit': '100'}]}]}, {'title': 'EOT visit: Klebsiella aerogenes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '80.0', 'groupId': 'OG000', 'lowerLimit': '37.1', 'upperLimit': '97.7'}]}]}, {'title': 'EOT visit: Klebsiella pneumoniae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '77.6', 'groupId': 'OG000', 'lowerLimit': '64.5', 'upperLimit': '87.4'}]}]}, {'title': 'EOT visit: Klebsiella variicola', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '14.7', 'upperLimit': '100'}]}]}, {'title': 'EOT visit: Morganella morganii', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '14.7', 'upperLimit': '100'}]}]}, {'title': 'EOT visit: Proteus mirabilis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '46.4', 'upperLimit': '100'}]}]}, {'title': 'EOT visit: Proteus vulgaris', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '14.7', 'upperLimit': '100'}]}]}, {'title': 'EOT visit: Providencia rettgeri', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '14.7', 'upperLimit': '100'}]}]}, {'title': 'EOT visit: Providencia stuartii', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '14.7', 'upperLimit': '100'}]}]}, {'title': 'EOT visit: Serratia marcescens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '14.7', 'upperLimit': '100'}]}]}, {'title': 'EOT visit: Acinetobacter baumannii', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '71.4', 'groupId': 'OG000', 'lowerLimit': '35.2', 'upperLimit': '93.5'}]}]}, {'title': 'EOT visit: Haemophilus influenzae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '55.5', 'upperLimit': '100'}]}]}, {'title': 'EOT visit: Moraxella catarrhalis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '85.3'}]}]}, {'title': 'EOT visit: Pseudomonas aeruginosa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000', 'lowerLimit': '50.9', 'upperLimit': '90.9'}]}]}, {'title': 'EOT visit: Stenotrophomonas maltophilia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '6.1', 'upperLimit': '93.9'}]}]}, {'title': 'EOT visit: Enterococcus faecium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '14.7', 'upperLimit': '100'}]}]}, {'title': 'EOT visit: Staphylococcus aureus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000', 'lowerLimit': '23.5', 'upperLimit': '86.1'}]}]}, {'title': 'EOT visit: Staphylococcus hominis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '14.7', 'upperLimit': '100'}]}]}, {'title': 'TOC visit: Enterobacter cloacae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000', 'lowerLimit': '3.9', 'upperLimit': '82.3'}]}]}, {'title': 'TOC visit: Escherichia coli', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '62.1', 'upperLimit': '100'}]}]}, {'title': 'TOC visit: Klebsiella aerogenes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '80.0', 'groupId': 'OG000', 'lowerLimit': '37.1', 'upperLimit': '97.7'}]}]}, {'title': 'TOC visit: Klebsiella pneumoniae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '53.1', 'groupId': 'OG000', 'lowerLimit': '39.2', 'upperLimit': '66.5'}]}]}, {'title': 'TOC visit: Klebsiella variicola', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '14.7', 'upperLimit': '100'}]}]}, {'title': 'TOC visit: Morganella morganii', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '14.7', 'upperLimit': '100'}]}]}, {'title': 'TOC visit: Proteus mirabilis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000', 'lowerLimit': '17.7', 'upperLimit': '96.1'}]}]}, {'title': 'TOC visit: Proteus vulgaris', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '14.7', 'upperLimit': '100'}]}]}, {'title': 'TOC visit: Providencia rettgeri', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '14.7', 'upperLimit': '100'}]}]}, {'title': 'TOC visit: Providencia stuartii', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '14.7', 'upperLimit': '100'}]}]}, {'title': 'TOC visit: Serratia marcescens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '14.7', 'upperLimit': '100'}]}]}, {'title': 'TOC visit: Acinetobacter baumannii', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '42.9', 'groupId': 'OG000', 'lowerLimit': '13.9', 'upperLimit': '76.5'}]}]}, {'title': 'TOC visit: Haemophilus influenzae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '55.5', 'upperLimit': '100'}]}]}, {'title': 'TOC visit: Moraxella catarrhalis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '85.3'}]}]}, {'title': 'TOC visit: Pseudomonas aeruginosa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '37.5', 'groupId': 'OG000', 'lowerLimit': '17.4', 'upperLimit': '61.7'}]}]}, {'title': 'TOC visit: Stenotrophomonas maltophilia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '66.7'}]}]}, {'title': 'TOC visit: Enterococcus faecium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '14.7', 'upperLimit': '100'}]}]}, {'title': 'TOC visit: Staphylococcus aureus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '42.9', 'groupId': 'OG000', 'lowerLimit': '13.9', 'upperLimit': '76.5'}]}]}, {'title': 'TOC visit: Staphylococcus hominis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '14.7', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'EOT visit: within 24 hours after the completion of the last infusion of study intervention (study treatment was a minimum of 7 days and maximum of 14 days); TOC visit: any day from Day 21 to 25', 'description': 'Favorable microbiological response included eradication (an adequate source specimen demonstrated absence of the original baseline pathogen) and presumed eradication (an adequate source specimen was not available to culture and the participant was assessed as a clinical cure). In this outcome measure percentage of participants with favorable per-pathogen microbiological response are recorded.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mMITT analysis set evaluated. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants in mMITT analysis set evaluable for specified pathogens and visits.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinical Cure at the EOT and TOC Visits in Participants With Gram-negative Baseline Pathogens Resistant to Ceftazidime: mMITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CAZ-AVI', 'description': 'Participants with HAP received CAZ-AVI, 2.5 g, IV as 2 hours infusion every 8 hours for a maximum of 14 days.'}], 'classes': [{'title': 'EOT visit', 'categories': [{'measurements': [{'value': '63.3', 'groupId': 'OG000', 'lowerLimit': '45.5', 'upperLimit': '78.7'}]}]}, {'title': 'TOC visit', 'categories': [{'measurements': [{'value': '53.3', 'groupId': 'OG000', 'lowerLimit': '35.9', 'upperLimit': '70.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'EOT visit: within 24 hours after the completion of the last infusion of study intervention (study treatment was a minimum of 7 days and maximum of 14 days); TOC visit: any day from Day 21 to 25', 'description': 'Clinical cure at EOT: participants were considered to be a success for clinical response at EOT visit if the participants were alive and all signs and symptoms of pneumonia were resolved or improved such that all antibacterial therapies for HAP/VAP were stopped. No antibacterial therapy other than those outlined by the protocol was administered for HAP prior to EOT. Clinical cure at TOC: participants were considered to be a success for clinical response at TOC visit if the participants were not a clinical failure at EOT, and the participants were alive and all signs and symptoms of pneumonia were resolved or improved to an extent that no antibacterial therapy for HAP was taken between EOT and TOC inclusive.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mMITT analysis set evaluated. Here, "Overall Number of Participants Analyzed" signifies number of participants who were evaluable for this outcome measure, i.e. participants in mMITT analysis set that with gram-negative baseline pathogens resistant to ceftazidime.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Favorable Per-Participant Microbiologic Response at the EOT and TOC Visits in Participants With Gram-negative Baseline Pathogens Resistant to Ceftazidime: mMITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CAZ-AVI', 'description': 'Participants with HAP received CAZ-AVI, 2.5 g, IV as 2 hours infusion every 8 hours for a maximum of 14 days.'}], 'classes': [{'title': 'EOT visit', 'categories': [{'measurements': [{'value': '73.3', 'groupId': 'OG000', 'lowerLimit': '55.9', 'upperLimit': '86.5'}]}]}, {'title': 'TOC visit', 'categories': [{'measurements': [{'value': '46.7', 'groupId': 'OG000', 'lowerLimit': '29.8', 'upperLimit': '64.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'EOT visit: within 24 hours after the completion of the last infusion of study intervention (study treatment was a minimum of 7 days and maximum of 14 days); TOC visit: any day from Day 21 to 25', 'description': 'For participants from whom only 1 causative pathogen is isolated, the overall microbiological response assessment was based on the microbiological response assessment for that pathogen. For participants from whom more than 1 baseline pathogen was isolated, the overall microbiological response assessment was "favorable" only if the microbiological response assessment for each of the baseline pathogens isolated was "favorable". Favorable microbiological response included eradication (an adequate source specimen demonstrated absence of the original baseline pathogen) and presumed eradication (an adequate source specimen was not available to culture and the participant was assessed as a clinical cure). In this outcome measure percentage of participants with favorable per-participant microbiological response are recorded.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mMITT analysis set evaluated. Here, "Overall Number of Participants Analyzed" signifies number of participants who were evaluable for this outcome measure, i.e. participants in mMITT analysis set that with gram-negative baseline pathogens resistant to ceftazidime.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Death Due to Any Cause at the TOC Visit and at Day 28 Visit: cMITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CAZ-AVI', 'description': 'Participants with HAP received CAZ-AVI, 2.5 g, IV as 2 hours infusion every 8 hours for a maximum of 14 days.'}], 'classes': [{'title': 'TOC visit', 'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000', 'lowerLimit': '3.2', 'upperLimit': '9.5'}]}]}, {'title': 'Day 28 visit', 'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000', 'lowerLimit': '3.2', 'upperLimit': '9.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'TOC visit: any day from Day 21 to 25; Day 28', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'cMITT: MITT subset and participants whose baseline respiratory or blood culture showed gram -ve pathogens with or without concomitant gram +ve pathogens (excluding those with gram -ve pathogens unexpected to respond to either study drug \\[participants with only monomicrobial gram -ve infection: any Acinetobacter species/ Legionella species/ Stenotrophomonas maltophilia/ Elizabethkingia meningoseptica\\]) or in whom no etiologic pathogens identified from respiratory or blood culture at baseline.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Death Due to Any Cause at the TOC Visit and at Day 28 Visit: mMITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CAZ-AVI', 'description': 'Participants with HAP received CAZ-AVI, 2.5 g, IV as 2 hours infusion every 8 hours for a maximum of 14 days.'}], 'classes': [{'title': 'TOC visit', 'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000', 'lowerLimit': '3.2', 'upperLimit': '14.8'}]}]}, {'title': 'Day 28 visit', 'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000', 'lowerLimit': '3.2', 'upperLimit': '14.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'TOC visit: any day from Day 21 to 25; Day 28', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "mMITT:MITT subset and participants with proper RC showing gram-ve pathogens,excluding participants unexpected to respond to CAZ-AVI (participants with only monomicrobial gram-ve infections:any Acinetobacter species/Legionella species/Stenotrophomonas maltophilia/Elizabethkingia meningoseptica).If baseline RC unavailable or didn't identify respiratory pathogen, but gram-ve organism causing pneumonia was identified from baseline blood cultures,participant qualified for mMITT."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CAZ-AVI', 'description': 'Participants with HAP received CAZ-AVI, 2.5 g, IV as 2 hours infusion every 8 hours for a maximum of 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '204', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 up to 32 days after last dose of CAZ-AVI (maximum up to 46 days; maximum treatment duration was of 14 days)', 'description': 'An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and all non-SAEs that occurred in the study. TEAEs were AEs between first dose of study treatment and up to 32 days post last dose that were absent before treatment or that worsened relative to pretreatment state.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants who had taken at least 1 dose of study intervention.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Post-Baseline Laboratory Test Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CAZ-AVI', 'description': 'Participants with HAP received CAZ-AVI, 2.5 g, IV as 2 hours infusion every 8 hours for a maximum of 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 up to 32 days after last dose of CAZ-AVI (maximum up to 46 days; maximum treatment duration was of 14 days)', 'description': 'Hematology: Hemoglobin (Hg), hematocrit, erythrocytes: less than (\\<)0.8\\*lower limit of normal (LLN) \\& change (chg) more than (\\>)20% decrease (dec); platelets: \\<0.65\\*LLN \\& chg \\>50% dec \\&, \\>1.5\\* upper limit of normal (ULN) \\& chg \\>100% increase (inc); leukocytes: \\<0.65\\*LLN \\& chg \\>60% dec \\&, \\>1.6\\*ULN \\& chg \\>100% inc; lymphocytes, \\<0.25\\*LLN \\& chg \\>75% dec; neutrophils: \\<0.65\\*LLN \\& chg \\>75% dec \\&, \\>1.6\\*ULN \\& chg \\>100% inc; basophils, monocytes: \\>4.0\\* ULN \\& chg \\>300% inc. Clinical chemistry: bilirubin: \\>2.0\\*ULN \\& chg \\>150% inc; aspartate aminotransferase (AT) \\& Alanine AT: \\>3.0\\*ULN \\& chg \\>200% inc; alkaline phosphatase \\<0.5\\*LLN \\& chg \\>80% dec \\& \\>2.0\\*ULN \\& chg \\>100% inc; creatinine: \\>2.0\\*ULN \\& \\>chg 100% inc; sodium: \\<0.85\\*LLN \\& chg \\>10% dec \\& \\>1.1\\*ULN \\& chg \\>10% inc; potassium \\& chloride: \\<0.8\\*LLN \\& chg \\>20% dec \\& \\>1.2\\*ULN \\& chg \\>20% dec; calcium: \\<0.7\\*LLN \\& chg \\>30% dec \\& bicarbonate: \\<0.7\\*LLN \\& chg \\>40% dec. Clinical significance was judged by investigator.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants who had taken at least 1 dose of study intervention. Here "Number of Participants Analyzed" includes number of participants evaluable for laboratory abnormalities.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Vital Signs Data According to Pre-defined Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CAZ-AVI', 'description': 'Participants with HAP received CAZ-AVI, 2.5 g, IV as 2 hours infusion every 8 hours for a maximum of 14 days.'}], 'classes': [{'title': 'Diastolic blood pressure: <50 mmHg', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure: Change >=20 mmHg increase', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure: Change >= 20 mmHg decrease', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}]}]}, {'title': 'Pulse rate: Value <40 bpm', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Pulse rate: Value >120 bpm', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure: Value <90 mmHg', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure: Change >= 30 mmHg increase', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure: Change >= 30 mmHg decrease', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 up to 32 days after last dose of CAZ-AVI (maximum up to 46 days; maximum treatment duration was of 14 days)', 'description': 'Vital signs included diastolic blood pressure (millimeters of mercury \\[mmHg\\]); pulse rate (beats per minute \\[bpm\\]) and systolic blood pressure (mmHg). Pre-defined criteria: Diastolic blood pressure: Value \\<50 mmHg, Diastolic blood pressure: Change more than or equal to (\\>=) 20 mmHg increase, Diastolic blood pressure: Change \\>= 20 mmHg decrease, Pulse rate: Value \\<40 bpm, Pulse rate: Value \\>120 bpm, Systolic blood pressure: Value \\<90 mmHg, Systolic blood pressure: Change \\>= 30 mmHg increase, Systolic blood pressure: Change \\>= 30 mmHg decrease. One participant could have more than one vital sign abnormality.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants who had taken at least 1 dose of study intervention.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ceftazidime-Avibactam (CAZ-AVI)', 'description': 'Participants received CAZ-AVI (Zavicefta), 2.5 grams (g) \\[ceftazidime 2g + avibactam 0.5g\\], intravenously (IV) as 2 hours infusion every 8 hours for a minimum of 7 days and a maximum of 14 days. Participants were followed up to maximum of 32 days after the last dose of study intervention.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '235'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '191'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'A total of 235 Chinese adult participants with hospital acquired pneumonia (HAP) \\[including ventilator-associated pneumonia {VA}\\] were enrolled.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'CAZ-AVI 1', 'description': 'Participants received CAZ-AVI (Zavicefta), 2.5 g (ceftazidime 2g + avibactam 0.5g), IV as 2 hours infusion every 8 hours for a minimum of 7 days and a maximum of 14 days. Participants were followed up to maximum of 32 days after the last dose of study intervention.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.0', 'spread': '14.36', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '69', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '166', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '235', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '235', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety analysis set (SAS) included all participants who had taken at least 1 dose of study intervention.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-02-07', 'size': 15703932, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-04-12T09:43', 'hasProtocol': True}, {'date': '2023-05-22', 'size': 870187, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-04-12T09:44', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 235}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-05-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-12', 'studyFirstSubmitDate': '2021-02-05', 'resultsFirstSubmitDate': '2024-04-12', 'studyFirstSubmitQcDate': '2021-02-25', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-12', 'studyFirstPostDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Clinical Cure at Test of Cure (TOC) Visit: Clinical Modified Intent-to-Treat (cMITT) Population', 'timeFrame': 'TOC visit: any day from Day 21 to 25', 'description': 'Clinical cure: participants were considered to be a success for clinical response at TOC visit if the participants were not a clinical failure at end of treatment (EOT), and the participants were alive and all signs and symptoms of pneumonia were resolved or improved to an extent that no antibacterial therapy for HAP was taken between EOT and TOC inclusive. Gram negative is abbreviated as gram -ve and gram positive as gram +ve.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Clinical Cure at EOT Visit: cMITT Population', 'timeFrame': 'EOT visit: within 24 hours after the completion of the last infusion of study intervention (study treatment was a minimum of 7 days and maximum of 14 days)', 'description': 'Clinical cure: participants were considered to be a success for clinical response at EOT visit if the participants were alive and all signs and symptoms of pneumonia were resolved or improved such that all antibacterial therapies for HAP/ VAP were stopped. No antibacterial therapy other than those outlined by the protocol was administered for HAP prior to EOT.'}, {'measure': 'Percentage of Participants With Clinical Cure at EOT and TOC Visit: Microbiological Modified Intent-to-Treat (mMITT) Population', 'timeFrame': 'EOT visit: within 24 hours after the completion of the last infusion of study intervention (study treatment was a minimum of 7 days and maximum of 14 days); TOC visit: any day from Day 21 to 25', 'description': 'Clinical cure at EOT: participants were considered to be a success for clinical response at EOT visit if the participants were alive and all signs and symptoms of pneumonia were resolved or improved such that all antibacterial therapies for HAP/VAP were stopped. No antibacterial therapy other than those outlined by the protocol was administered for HAP prior to EOT. Clinical cure at TOC: participants were considered to be a success for clinical response at TOC visit if the participants were not a clinical failure at EOT, and the participants were alive and all signs and symptoms of pneumonia were resolved or improved to an extent that no antibacterial therapy for HAP was taken between EOT and TOC inclusive.'}, {'measure': 'Percentage of Participants With Favorable Per-Participant Microbiological Response at the EOT and TOC Visits: mMITT Population', 'timeFrame': 'EOT visit: within 24 hours after the completion of the last infusion of study intervention (study treatment was a minimum of 7 days and maximum of 14 days); TOC visit: any day from Day 21 to 25', 'description': 'For participants from whom only 1 causative pathogen is isolated, the overall microbiological response assessment was based on the microbiological response assessment for that pathogen. For participants from whom more than 1 baseline pathogen was isolated, the overall microbiological response assessment was "favorable" only if the microbiological response assessment for each of the baseline pathogens isolated was "favorable". Favorable microbiological response included eradication (an adequate source specimen demonstrated absence of the original baseline pathogen) and presumed eradication (an adequate source specimen was not available to culture and the participant was assessed as a clinical cure). In this outcome measure percentage of participants with favorable per-participant microbiological response are recorded.'}, {'measure': 'Percentage of Participants With Favorable Per-Pathogen Microbiological Response at the EOT and TOC Visits: mMITT Population', 'timeFrame': 'EOT visit: within 24 hours after the completion of the last infusion of study intervention (study treatment was a minimum of 7 days and maximum of 14 days); TOC visit: any day from Day 21 to 25', 'description': 'Favorable microbiological response included eradication (an adequate source specimen demonstrated absence of the original baseline pathogen) and presumed eradication (an adequate source specimen was not available to culture and the participant was assessed as a clinical cure). In this outcome measure percentage of participants with favorable per-pathogen microbiological response are recorded.'}, {'measure': 'Percentage of Participants With Clinical Cure at the EOT and TOC Visits in Participants With Gram-negative Baseline Pathogens Resistant to Ceftazidime: mMITT Population', 'timeFrame': 'EOT visit: within 24 hours after the completion of the last infusion of study intervention (study treatment was a minimum of 7 days and maximum of 14 days); TOC visit: any day from Day 21 to 25', 'description': 'Clinical cure at EOT: participants were considered to be a success for clinical response at EOT visit if the participants were alive and all signs and symptoms of pneumonia were resolved or improved such that all antibacterial therapies for HAP/VAP were stopped. No antibacterial therapy other than those outlined by the protocol was administered for HAP prior to EOT. Clinical cure at TOC: participants were considered to be a success for clinical response at TOC visit if the participants were not a clinical failure at EOT, and the participants were alive and all signs and symptoms of pneumonia were resolved or improved to an extent that no antibacterial therapy for HAP was taken between EOT and TOC inclusive.'}, {'measure': 'Percentage of Participants With Favorable Per-Participant Microbiologic Response at the EOT and TOC Visits in Participants With Gram-negative Baseline Pathogens Resistant to Ceftazidime: mMITT Population', 'timeFrame': 'EOT visit: within 24 hours after the completion of the last infusion of study intervention (study treatment was a minimum of 7 days and maximum of 14 days); TOC visit: any day from Day 21 to 25', 'description': 'For participants from whom only 1 causative pathogen is isolated, the overall microbiological response assessment was based on the microbiological response assessment for that pathogen. For participants from whom more than 1 baseline pathogen was isolated, the overall microbiological response assessment was "favorable" only if the microbiological response assessment for each of the baseline pathogens isolated was "favorable". Favorable microbiological response included eradication (an adequate source specimen demonstrated absence of the original baseline pathogen) and presumed eradication (an adequate source specimen was not available to culture and the participant was assessed as a clinical cure). In this outcome measure percentage of participants with favorable per-participant microbiological response are recorded.'}, {'measure': 'Percentage of Participants With Death Due to Any Cause at the TOC Visit and at Day 28 Visit: cMITT Population', 'timeFrame': 'TOC visit: any day from Day 21 to 25; Day 28'}, {'measure': 'Percentage of Participants With Death Due to Any Cause at the TOC Visit and at Day 28 Visit: mMITT Population', 'timeFrame': 'TOC visit: any day from Day 21 to 25; Day 28'}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': 'Day 1 up to 32 days after last dose of CAZ-AVI (maximum up to 46 days; maximum treatment duration was of 14 days)', 'description': 'An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and all non-SAEs that occurred in the study. TEAEs were AEs between first dose of study treatment and up to 32 days post last dose that were absent before treatment or that worsened relative to pretreatment state.'}, {'measure': 'Number of Participants With Clinically Significant Post-Baseline Laboratory Test Abnormalities', 'timeFrame': 'Day 1 up to 32 days after last dose of CAZ-AVI (maximum up to 46 days; maximum treatment duration was of 14 days)', 'description': 'Hematology: Hemoglobin (Hg), hematocrit, erythrocytes: less than (\\<)0.8\\*lower limit of normal (LLN) \\& change (chg) more than (\\>)20% decrease (dec); platelets: \\<0.65\\*LLN \\& chg \\>50% dec \\&, \\>1.5\\* upper limit of normal (ULN) \\& chg \\>100% increase (inc); leukocytes: \\<0.65\\*LLN \\& chg \\>60% dec \\&, \\>1.6\\*ULN \\& chg \\>100% inc; lymphocytes, \\<0.25\\*LLN \\& chg \\>75% dec; neutrophils: \\<0.65\\*LLN \\& chg \\>75% dec \\&, \\>1.6\\*ULN \\& chg \\>100% inc; basophils, monocytes: \\>4.0\\* ULN \\& chg \\>300% inc. Clinical chemistry: bilirubin: \\>2.0\\*ULN \\& chg \\>150% inc; aspartate aminotransferase (AT) \\& Alanine AT: \\>3.0\\*ULN \\& chg \\>200% inc; alkaline phosphatase \\<0.5\\*LLN \\& chg \\>80% dec \\& \\>2.0\\*ULN \\& chg \\>100% inc; creatinine: \\>2.0\\*ULN \\& \\>chg 100% inc; sodium: \\<0.85\\*LLN \\& chg \\>10% dec \\& \\>1.1\\*ULN \\& chg \\>10% inc; potassium \\& chloride: \\<0.8\\*LLN \\& chg \\>20% dec \\& \\>1.2\\*ULN \\& chg \\>20% dec; calcium: \\<0.7\\*LLN \\& chg \\>30% dec \\& bicarbonate: \\<0.7\\*LLN \\& chg \\>40% dec. Clinical significance was judged by investigator.'}, {'measure': 'Number of Participants With Vital Signs Data According to Pre-defined Criteria', 'timeFrame': 'Day 1 up to 32 days after last dose of CAZ-AVI (maximum up to 46 days; maximum treatment duration was of 14 days)', 'description': 'Vital signs included diastolic blood pressure (millimeters of mercury \\[mmHg\\]); pulse rate (beats per minute \\[bpm\\]) and systolic blood pressure (mmHg). Pre-defined criteria: Diastolic blood pressure: Value \\<50 mmHg, Diastolic blood pressure: Change more than or equal to (\\>=) 20 mmHg increase, Diastolic blood pressure: Change \\>= 20 mmHg decrease, Pulse rate: Value \\<40 bpm, Pulse rate: Value \\>120 bpm, Systolic blood pressure: Value \\<90 mmHg, Systolic blood pressure: Change \\>= 30 mmHg increase, Systolic blood pressure: Change \\>= 30 mmHg decrease. One participant could have more than one vital sign abnormality.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hospital-Acquired Pneumonia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=C3591026', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective, single arm, open-label, multi-center clinical study evaluating the effectiveness and safety of CAZ-AVI in participants with HAP (including VAP), who have initiated treatment with CAZ-AVI in an inpatient hospital setting. The duration of antibiotic treatment with the CAZ-AVI is 7-14 days. Participants must receive intravenously (IV) CAZ-AVI in the hospital for at least 7 full days. There are no formal hypothesis tests planned for this study. The number and percent of participants having clinical cure, failure, and indeterminate at TOC visit in the cMITT analysis population will be summarized.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female participants ≥18 and ≤90 years of age.\n* Onset of symptoms ≥48 hours after admission or \\<7 days after discharge from an inpatient acute or chronic care facility.\n* New or worsening infiltrate on chest X-ray obtained within 48 hours prior to screening.\n* Participants have systemic signs and respiratory signs or symptoms of HAP/VAP\n\nExclusion Criteria:\n\n* Other medical or psychiatric condition may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.\n* Participant is expected to require a treatment course for HAP longer than 14 days.\n* The total duration of antibiotic exposure for antibiotics whose administration begins in the 48 hours is longer than 24 hours.\n* Previous administration with an investigational drug within 30 days or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer).\n* Acute Physiology and Chronic Health Evaluation (APACHE) II score \\>30 or \\<10 using the most recent available data."}, 'identificationModule': {'nctId': 'NCT04774094', 'briefTitle': 'Efficacy and Safety of Ceftazidime-Avibactam (CAZ-AVI) in Chinese Participants With HAP (Including VAP)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A SINGLE ARM, OPEN-LABEL, MULTI-CENTER, INTERVENTIONAL STUDY EVALUATING THE EFFICACY AND SAFETY OF CEFTAZIDIME-AVIBACTAM (CAZ-AVI) IN CHINESE ADULTS WITH HAP (INCLUDING VAP)', 'orgStudyIdInfo': {'id': 'C3591026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CAZ-AVI', 'interventionNames': ['Drug: Zavicefta, Ceftazidime-Avibactam']}], 'interventions': [{'name': 'Zavicefta, Ceftazidime-Avibactam', 'type': 'DRUG', 'description': 'Participants will receive CAZ-AVI (2000 mg of ceftazidime and 500 mg of avibactam) administered by IV infusion in a volume of 100 mL at a constant rate over 2 hours.', 'armGroupLabels': ['CAZ-AVI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '236000', 'city': 'Fuyang', 'state': 'Anhui', 'country': 'China', 'facility': "Fuyang People's Hospital", 'geoPoint': {'lat': 32.9, 'lon': 115.81667}}, {'zip': '100191', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '350005', 'city': 'Fuzhou', 'state': 'Fujian', 'country': 'China', 'facility': 'The First Affiliated Hospital of Fujian Medical University', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'zip': '361004', 'city': 'Xiamen', 'state': 'Fujian', 'country': 'China', 'facility': 'Zhongshan Hospital Xiamen University', 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}, {'zip': '510180', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': "Guangzhou First People's Hospital", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510280', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'ZhuJiang Hospital of Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510630', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The First Affiliated Hospital of Jinan University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '516008', 'city': 'Huizhou', 'state': 'Guangdong', 'country': 'China', 'facility': "Huizhou Central People's Hospital", 'geoPoint': {'lat': 23.11147, 'lon': 114.41523}}, {'zip': '511500', 'city': 'Qingyuan', 'state': 'Guangdong', 'country': 'China', 'facility': "Qingyuan People's Hospital", 'geoPoint': {'lat': 23.7, 'lon': 113.03333}}, {'zip': '518020', 'city': 'Shenzhen', 'state': 'Guangdong', 'country': 'China', 'facility': "Shenzhen People's Hospital", 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'zip': '518035', 'city': 'Shenzhen', 'state': 'Guangdong', 'country': 'China', 'facility': "The Second People's Hospital of Shenzhen", 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'zip': '524000', 'city': 'Zhanjiang', 'state': 'Guangdong', 'country': 'China', 'facility': 'Affiliated Hospital of Guangdong Medical University', 'geoPoint': {'lat': 21.23391, 'lon': 110.38749}}, {'zip': '524045', 'city': 'Zhanjiang', 'state': 'Guangdong', 'country': 'China', 'facility': "Central People's Hospital of Zhanjiang", 'geoPoint': {'lat': 21.23391, 'lon': 110.38749}}, {'zip': '530022', 'city': 'Nanning', 'state': 'Guangxi', 'country': 'China', 'facility': "The First People's Hospital of Nanning", 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}, {'zip': '563000', 'city': 'Zunyi', 'state': 'Guizhou', 'country': 'China', 'facility': 'The Affiliated Hospital of Zunyi Medical University', 'geoPoint': {'lat': 27.68667, 'lon': 106.90722}}, {'zip': '570311', 'city': 'Haikou', 'state': 'Hainan', 'country': 'China', 'facility': 'Hainan General Hospital', 'geoPoint': {'lat': 20.03421, 'lon': 110.34651}}, {'zip': '572022', 'city': 'Sanya', 'state': 'Hainan', 'country': 'China', 'facility': "Sanya People's Hospital", 'geoPoint': {'lat': 18.25435, 'lon': 109.50947}}, {'zip': '071000', 'city': 'Baoding', 'state': 'Hebei', 'country': 'China', 'facility': 'Affiliated Hospital of Hebei University', 'geoPoint': {'lat': 38.87288, 'lon': 115.46246}}, {'zip': '471009', 'city': 'Luoyang', 'state': 'Henan', 'country': 'China', 'facility': 'Luoyang Central Hospital', 'geoPoint': {'lat': 34.67345, 'lon': 112.43684}}, {'zip': '473000', 'city': 'Nanyang', 'state': 'Henan', 'country': 'China', 'facility': 'NanYang central hospital', 'geoPoint': {'lat': 32.99472, 'lon': 112.53278}}, {'zip': '47300', 'city': 'Nanyang', 'state': 'Henan', 'country': 'China', 'facility': "NanYang First people's hospital", 'geoPoint': {'lat': 32.99472, 'lon': 112.53278}}, {'zip': '450003', 'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': "Henan provincial people's hospital", 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '442000', 'city': 'Shiyan', 'state': 'Hubei', 'country': 'China', 'facility': 'Shiyan Renmin Hospital', 'geoPoint': {'lat': 32.6475, 'lon': 110.77806}}, {'zip': '430058', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '430060', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Renmin Hospital of Wuhan University', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '410005', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': "Hunan Provincial People's Hospital", 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '414020', 'city': 'Yueyang', 'state': 'Hunan', 'country': 'China', 'facility': "Yueyang People's Hospital", 'geoPoint': {'lat': 29.37455, 'lon': 113.09481}}, {'zip': '014000', 'city': 'Baotou', 'state': 'Inner Mongolia', 'country': 'China', 'facility': 'Baotou Central Hospital', 'geoPoint': {'lat': 40.6516, 'lon': 109.84389}}, {'zip': '014040', 'city': 'Baotou', 'state': 'Inner Mongolia', 'country': 'China', 'facility': 'Baotou Central Hospital', 'geoPoint': {'lat': 40.6516, 'lon': 109.84389}}, {'zip': '223300', 'city': "Huai'an", 'state': 'Jiangsu', 'country': 'China', 'facility': "Huai'an First People's Hospital", 'geoPoint': {'lat': 33.58861, 'lon': 119.01917}}, {'zip': '214400', 'city': 'Jiangyin', 'state': 'Jiangsu', 'country': 'China', 'facility': "Jiangyin People's Hospital", 'geoPoint': {'lat': 31.91102, 'lon': 120.26302}}, {'zip': '222002', 'city': 'Lianyungang', 'state': 'Jiangsu', 'country': 'China', 'facility': "The First People's Hospital of Lianyungang City", 'geoPoint': {'lat': 34.59845, 'lon': 119.21556}}, {'zip': '225300', 'city': 'Taizhou', 'state': 'Jiangsu', 'country': 'China', 'facility': "Taizhou People's Hospital", 'geoPoint': {'lat': 32.49069, 'lon': 119.90812}}, {'zip': '214122', 'city': 'Wuxi', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Affiliated Hospital of Jiangnan University', 'geoPoint': {'lat': 31.56887, 'lon': 120.28857}}, {'zip': '221002', 'city': 'Xuzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'The Affiliated Hospital of Xuzhou Medical University', 'geoPoint': {'lat': 34.20442, 'lon': 117.28386}}, {'zip': '225001', 'city': 'Yangzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': "Subei People's Hospital of Jiangsu province", 'geoPoint': {'lat': 32.39722, 'lon': 119.43583}}, {'zip': '330038', 'city': 'Nanchang', 'state': 'Jiangxi', 'country': 'China', 'facility': "Jiangxi Provincial People's Hospital", 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'zip': '116001', 'city': 'Dalian', 'state': 'Liaoning', 'country': 'China', 'facility': 'Affiliated Zhongshan Hospital of Dalian University', 'geoPoint': {'lat': 38.91222, 'lon': 121.60222}}, {'zip': '110016', 'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'General Hospital of Northern Theater Command', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '750004', 'city': 'Yinchuan', 'state': 'Ningxia', 'country': 'China', 'facility': 'General Hospital of Ningxia Medical University', 'geoPoint': {'lat': 38.46806, 'lon': 106.27306}}, {'zip': '200040', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Huashan Hospital Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'West China Hospital of Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '610055', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'Chengdu Xinhua Hospital', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '300052', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Tianjin Medical University General Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '300222', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Tianjin Chest Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '650034', 'city': 'Kunming', 'state': 'Yunnan', 'country': 'China', 'facility': 'The First Hospital of Kunming', 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}, {'zip': '322199', 'city': 'Dongyang', 'state': 'Zhejiang', 'country': 'China', 'facility': "Dongyang People's Hospital", 'geoPoint': {'lat': 29.26778, 'lon': 120.22528}}, {'zip': '310013', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Zhejiang Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '310014', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': "Zhejiang Provincial People's Hospital", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '310016', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '310030', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Zhejiang Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '325035', 'city': 'Wenzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The 2nd Affiliated Hospital of WMU', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}, {'zip': '325099', 'city': 'Wenzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Wenzhou Central Hospital', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}, {'city': 'Beijing', 'country': 'China', 'facility': "Seventh Medical Center, The General Hospital of People's Liberation Army", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '200240', 'city': 'Shanghai', 'country': 'China', 'facility': "Shanghai Fifth People's Hospital, Fudan University", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Xiamen', 'country': 'China', 'facility': 'Zhongshan Hospital Xiamen University', 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'url': 'https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests', 'ipdSharing': 'YES', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}