Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2026-03-02 @ 10:05 PM
Study NCT ID:
NCT01561794
Status:
COMPLETED
Last Update Posted:
2015-04-27
First Post:
2012-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase III Study to Evaluate the Safety, Efficacy and Pharmacokinetics/Pharmacodynamics of BAYQ3939 in Patients With Bacterial Pneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D018410', 'term': 'Pneumonia, Bacterial'}, {'id': 'D000098968', 'term': 'Community-Acquired Pneumonia'}, {'id': 'D000077299', 'term': 'Healthcare-Associated Pneumonia'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D017714', 'term': 'Community-Acquired Infections'}, {'id': 'D003428', 'term': 'Cross Infection'}, {'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': 'D002939', 'term': 'Ciprofloxacin'}], 'ancestors': [{'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-24', 'studyFirstSubmitDate': '2012-03-21', 'studyFirstSubmitQcDate': '2012-03-21', 'lastUpdatePostDateStruct': {'date': '2015-04-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety variables will be summarized using descriptive statistics based on adverse events collection', 'timeFrame': 'Up to 30 (±5) days after the end of treatment'}, {'measure': 'AUC (Area under the blood concentration/time curve)', 'timeFrame': 'Within 0-24 hours and 48-72 hours after the first study drug administration'}, {'measure': 'Cmax (Maximum observed concentration)', 'timeFrame': 'Within 0-24 hours and 48-72 hours after the first study drug administration'}, {'measure': 'AUC/MIC (Minimum inhibitory concentration)', 'timeFrame': 'Within 0-24 hours and 48-72 hours after the first study drug administration'}, {'measure': 'Cmax/MIC', 'timeFrame': 'Within 0-24 hours and 48-72 hours after the first study drug administration'}, {'measure': 'AUC/MPC (Mutant prevention concentration)', 'timeFrame': 'Within 0-24 hours and 48-72 hours after the first study drug administration'}, {'measure': 'Cmax/MPC', 'timeFrame': 'Within 0-24 hours and 48-72 hours after the first study drug administration'}], 'secondaryOutcomes': [{'measure': 'Clinical response rate based on resolution of signs and symptoms', 'timeFrame': 'Up to 13 days after the first study drug administration'}, {'measure': 'Microbiological response rate, assessed as eradication rate based on microbiologically evaluable patients', 'timeFrame': 'Up to 23 days after the first study drug administration'}, {'measure': 'Test of cure rate based on resolution of signs, symptoms, and the clinical response', 'timeFrame': 'Up to 23 days after the first study drug administration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ciprofloxacin', 'Bacterial pneumonia', 'Community Acquired Pneumonia (CAP)', 'Hospital Acquired Pneumonia (HAP)', 'Secondary infection of chronic respiratory disease', '400 mg BID/TID'], 'conditions': ['Pneumonia']}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to investigate the safety, pharmacokinetics (PK) and the relationship between PK and pharmacodynamics (Minimum Inhibitory Concentration \\[MIC\\] and Mutant Prevention Concentration \\[MPC\\]) of intravenous BAYQ3939 (400 mg BID and 400 mg TID) in hospitalized patients with bacterial pneumonia or secondary infection of chronic respiratory disease with severe disease or a poor response to other antimicrobials. In addition, the efficacy of the ciprofloxacin, in terms of clinical response and microbiological response, will be investigated, but as a secondary endpoint.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Males and non-pregnant, non-lactating females with written informed consent, 20 years of age or older.\n* Within 48 hours prior to the first study drug administration, all patients should have the pathogens identified with appropriate specimens (e.g., sputum, tracheal aspirate, bronchoalveolar lavage \\[BAL\\], protected brushing specimen \\[PBS\\]), or should have appropriate specimens highly likely to identify the pathogens sampled. (However, the patients with Legionellosis is enrolled when the test of Legionella antigen is positive.)\n* The following severe bacterial pneumonia meeting the diagnostic criteria of pneumonia or secondary infection of chronic respiratory disease\n\n * Severe pneumonia\n\n * Community-acquired pneumonia: PORT score III, IV or V\n * Hospital-acquired pneumonia \\[HAP\\]-Group B and with a low risk for multidrug-resistant pathogens\n * Patients with \\[HAP\\]-Group A whose pathogen is suspected to be Pseudomonas aeruginosa\n * Hospitalized patients with bacterial pneumonia with a poor response to other antimicrobials Note: The patients should be limited to CAP patients with PORT score III, IV or V and HAP patients with-Group A or B who don't respond to or have a poor response to other antimicrobials over 3day's treatment.2\n * Secondary infection of chronic respiratory disease\n\n * Patients who are hospitalized for the treatment of secondary infection of chronic respiratory disease\n * Hospitalized patients with secondary infection of chronic respiratory disease with a poor response to other antimicrobials Note: The patients should be limited to secondary infection of chronic respiratory disease patients who don't respond to or have a poor response to other antimicrobials over 3day's treatment.\n\nExclusion Criteria:\n\n* Creatinine clearance (Ccr) ≤ 30 mL/min or nephrotic syndrome\n* Patient with chronic treatment of immunosuppressive drug\n* Decompensated congestive heart failure\n* Subject who received more than 24 hours of an antibacterial drug for the current infection\n* Patient who requires Intensive Care Unit (ICU) management \\[In case subjects who don't correspond to the severity for ICU management need to be admitted to ICU due to a circumstance of the site (e.g. shortage of hospital beds), those subjects shall not be excluded\\]\n* Patients with infections other than pneumonia or secondary infection of chronic pulmonary disease\n* Lung abscess, or empyema\n* Viral, fungal, mycobacterial, or atypical pneumonia as a primary diagnosis\n* Known or suspected bacteremia secondary to Staphylococcus aureus\n* Known causative microorganisms other than indication (microorganisms) of the study drug, or positive in urinary antigen test of Streptococcus pneumonia\n* Infection that necessitates the use of a concomitant antibacterial agent in addition to study medication \\[excluding subjects with concomitant use of long-term, low-dose macrolide for chronic respiratory diseases, sulbactam sodium/ampicillin sodium (Unasyn-S) and clindamycin (Dalacin-S)\\]\n* Known bronchial obstruction or a history of post-obstructive pneumonia\n* Known primary lung cancer"}, 'identificationModule': {'nctId': 'NCT01561794', 'briefTitle': 'A Phase III Study to Evaluate the Safety, Efficacy and Pharmacokinetics/Pharmacodynamics of BAYQ3939 in Patients With Bacterial Pneumonia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'A Prospective, Non-randomized, Open-label, Non-controlled, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics/ Pharmacodynamics of BAYQ3939 (400 mg BID and TID) in Hospitalized Patients With Bacterial Pneumonia or Secondary Infection of Chronic Respiratory Disease With Severe Disease or a Poor Response to Other Antimicrobials', 'orgStudyIdInfo': {'id': '15992'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ciprofloxacin', 'interventionNames': ['Drug: Ciprofloxacin (Cipro, BAYQ3939)']}], 'interventions': [{'name': 'Ciprofloxacin (Cipro, BAYQ3939)', 'type': 'DRUG', 'description': '(1) Community-acquired pneumonia (CAP): 400 mg BID, i.e. every 12 ± 1 hours (For those with Ccr \\> 60 mL/min, 400 mg TID, i.e. every 8 ± 1 hours may be considered at the discretion of investigators) for 7 to 14 days.\n\n2\\) Hospital-acquired pneumonia (HAP): For the patient with Ccr \\> 60 mL/min, 400 mg TID, i.e. every 8 ± 1hours for 7 to 14 days For the patient with 30 ≤Ccr ≤60 mL/min, 400 mg BID, i.e. every 12 ± 1hours for 7 to 14 days 3) Secondary infection of chronic respiratory disease 400 mg BID, i.e. every 12 ± 1 hours (For those with of Ccr \\> 60 mL/min, 400 mg TID, i.e. every 8 ± 1 hours may be considered at the discretion of investigators) for 7 to 14 days.', 'armGroupLabels': ['Ciprofloxacin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '480-1195', 'city': 'Nagakute', 'state': 'Aichi-ken', 'country': 'Japan', 'geoPoint': {'lat': 35.17325, 'lon': 137.05667}}, {'zip': '650-0047', 'city': 'Kobe', 'state': 'Hyōgo', 'country': 'Japan', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'zip': '920-0293', 'city': 'Kahoku-gun', 'state': 'Ishikawa-ken', 'country': 'Japan'}, {'zip': '232-0024', 'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '854-8501', 'city': 'Isahaya', 'state': 'Nagasaki', 'country': 'Japan', 'geoPoint': {'lat': 32.84111, 'lon': 130.04306}}, {'zip': '859-0497', 'city': 'Isahaya', 'state': 'Nagasaki', 'country': 'Japan', 'geoPoint': {'lat': 32.84111, 'lon': 130.04306}}, {'zip': '850-8555', 'city': 'Nagasaki', 'state': 'Nagasaki', 'country': 'Japan', 'geoPoint': {'lat': 32.75, 'lon': 129.88333}}, {'zip': '852-8501', 'city': 'Nagasaki', 'state': 'Nagasaki', 'country': 'Japan', 'geoPoint': {'lat': 32.75, 'lon': 129.88333}}, {'zip': '852-8511', 'city': 'Nagasaki', 'state': 'Nagasaki', 'country': 'Japan', 'geoPoint': {'lat': 32.75, 'lon': 129.88333}}, {'zip': '857-8511', 'city': 'Sasebo', 'state': 'Nagasaki', 'country': 'Japan', 'geoPoint': {'lat': 33.16834, 'lon': 129.72502}}, {'zip': '854-0301', 'city': 'Unzen', 'state': 'Nagasaki', 'country': 'Japan', 'geoPoint': {'lat': 32.77111, 'lon': 130.24841}}, {'zip': '950-1197', 'city': 'Niigata', 'state': 'Niigata', 'country': 'Japan', 'geoPoint': {'lat': 37.92259, 'lon': 139.04125}}, {'zip': '950-2087', 'city': 'Niigata', 'state': 'Niigata', 'country': 'Japan', 'geoPoint': {'lat': 37.92259, 'lon': 139.04125}}, {'zip': '951-8520', 'city': 'Niigata', 'state': 'Niigata', 'country': 'Japan', 'geoPoint': {'lat': 37.92259, 'lon': 139.04125}}, {'zip': '879-5593', 'city': 'Yufu', 'state': 'Oita Prefecture', 'country': 'Japan', 'geoPoint': {'lat': 33.1956, 'lon': 131.37829}}, {'zip': '700-8607', 'city': 'Okayama', 'state': 'Okayama-ken', 'country': 'Japan', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'zip': '596-8501', 'city': 'Kishiwada', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.46667, 'lon': 135.36667}}, {'zip': '543-0035', 'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '843-0393', 'city': 'Ureshino', 'state': 'Saga-ken', 'country': 'Japan', 'geoPoint': {'lat': 33.13525, 'lon': 130.05718}}, {'zip': '434-8511', 'city': 'Hamamatsu', 'state': 'Shizuoka', 'country': 'Japan', 'geoPoint': {'lat': 34.7, 'lon': 137.73333}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}