Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
Study NCT ID:
NCT00827502
Status:
COMPLETED
Last Update Posted:
2011-04-28
First Post:
2009-01-21
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Trulimax (Azithromycin ) Non-Interventional Study In Acute Bacterial Upper Respiratory Tract Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.govCallCenter@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 \\< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \\< 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': {'eventGroups': [{'id': 'EG000', 'title': 'Azithromycin', 'otherNumAtRisk': 410, 'otherNumAffected': 16, 'seriousNumAtRisk': 410, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Gastric disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hyperchlorhydria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Adverse event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Drug intolerance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects With an Investigator Assessment of Clinical Outcome (Success/Failure) at End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '408', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Azithromycin'}], 'classes': [{'title': 'Success', 'categories': [{'measurements': [{'value': '275', 'groupId': 'OG000'}]}]}, {'title': 'Failure (Unknown or missing values also included)', 'categories': [{'measurements': [{'value': '133', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 2 weeks', 'description': 'Success: Cure (disappearance of all pre-treatment signs and symptoms of infection) or improvement in or partial disappearance of signs and symptoms not requiring further treatment at end of study; Failure: No change in, or worsening of baseline signs and symptoms requiring modification of treatment, ie, addition of or switch to another systemic antibacterial therapy. Unknown or missing values were considered as failure.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) included all subjects who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Cost (in Indian Rupees) Per Participant of Utilizations Including General Consultations, Medications, Chest X-ray, Complete Blood Count, and Erythrocyte Sedimentation Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '410', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Azithromycin'}], 'classes': [{'title': 'General Consultations (n=346)', 'categories': [{'measurements': [{'value': '500', 'groupId': 'OG000', 'lowerLimit': '150', 'upperLimit': '1300'}]}]}, {'title': 'Overall Study Drugs (n=390)', 'categories': [{'measurements': [{'value': '170', 'groupId': 'OG000', 'lowerLimit': '85', 'upperLimit': '272'}]}]}, {'title': 'Analgesics (n=205)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '112'}]}]}, {'title': 'Antipyretics (n=116)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '21'}]}]}, {'title': 'Anti-inflammatory (n=88)', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '84'}]}]}, {'title': 'Vitamins (n=180)', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '70'}]}]}, {'title': 'Other study medication (n=235)', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '96'}]}]}, {'title': 'Chest X-ray (n=9)', 'categories': [{'measurements': [{'value': '150', 'groupId': 'OG000', 'lowerLimit': '150', 'upperLimit': '150'}]}]}, {'title': 'Complete Blood Count (n=15)', 'categories': [{'measurements': [{'value': '200', 'groupId': 'OG000', 'lowerLimit': '200', 'upperLimit': '200'}]}]}, {'title': 'Erythrocyte Sedimentation Rate (n=4)', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000', 'lowerLimit': '80', 'upperLimit': '80'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to 3 months', 'description': 'Cost (in Indian Rupees) per participant of utilizations including general consultations over the study; each medication over the study (study drug, analgesics, antipyretics, anti-inflammatory drugs, vitamins, other study medication), radiological tests over the study (chest X-ray); and clinical laboratory tests over the study (complete blood count and erythrocyte sedimentation rate).', 'unitOfMeasure': 'cost (in Indian Rupees) per participant', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With an Investigator Assessment of Clinical Outcome (Cure/Improvement/Failure) at End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Azithromycin'}], 'classes': [{'title': 'Cure', 'categories': [{'measurements': [{'value': '249', 'groupId': 'OG000'}]}]}, {'title': 'Improvement', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'Failure', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 2 weeks', 'description': 'Cure: Disappearance of all pre-treatment signs and symptoms of infection; Improvement: Improvement in, or partial disappearance of signs and symptoms without requiring further antibacterial therapy. Subjects who discontinued study drug for reasons other than lack of clinical response, i.e., despite clinical improvement, were included in this category; and Failure: No change in, or worsening of baseline signs and symptoms requiring modification of treatment, ie, addition of or switch to another systemic antibacterial therapy. An unknown response or missing value was considered clinical failure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy evaluable (EVAL) population included subjects in the FAS having at least 1 definitive follow up global response assessment to treatment of URTIs.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Azithromycin', 'description': 'The use and dosage recommendations for Azithromycin took place on the basis of the approved local product document (LPD) and were adjusted solely according to medical and therapeutic necessities. According to the approved LPD, in general a total dose of 30 mg/kg was given as a single daily dose(10 mg/kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/kg on day 1, and then reduced to 5 mg/kg on days 2 to 5). For children with acute otitis media a single dose of 30 mg/kg was recommended. Children with streptococcal pharyngitis were given a single dose of 10 mg/kg or 20 mg/kg for 3 days and did not exceed a daily dose of 500mg. The maximum recommended total dose of Azithromycin in children for any treatment was 1500 mg. Azithromycin tablets were administered only to children weighing more than 45 kg.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '421'}]}, {'type': 'Received Treatment (Number Treated)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '410'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '400'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}], 'dropWithdraws': [{'type': 'randomized but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '410', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Azithromycin'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<18 years', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}]}]}, {'title': '18-44 years', 'categories': [{'measurements': [{'value': '270', 'groupId': 'BG000'}]}]}, {'title': '45-64 years', 'categories': [{'measurements': [{'value': '73', 'groupId': 'BG000'}]}]}, {'title': '>= 65 years', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'Unspecified', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Demographic information not collected', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '155', 'groupId': 'BG000'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '245', 'groupId': 'BG000'}]}]}, {'title': 'Unspecified', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Demographic information not collected', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 421}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-25', 'studyFirstSubmitDate': '2009-01-21', 'resultsFirstSubmitDate': '2010-03-30', 'studyFirstSubmitQcDate': '2009-01-21', 'lastUpdatePostDateStruct': {'date': '2011-04-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-05-17', 'studyFirstPostDateStruct': {'date': '2009-01-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-06-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects With an Investigator Assessment of Clinical Outcome (Success/Failure) at End of Study', 'timeFrame': 'Baseline to 2 weeks', 'description': 'Success: Cure (disappearance of all pre-treatment signs and symptoms of infection) or improvement in or partial disappearance of signs and symptoms not requiring further treatment at end of study; Failure: No change in, or worsening of baseline signs and symptoms requiring modification of treatment, ie, addition of or switch to another systemic antibacterial therapy. Unknown or missing values were considered as failure.'}, {'measure': 'Number of Subjects With an Investigator Assessment of Clinical Outcome (Cure/Improvement/Failure) at End of Study', 'timeFrame': 'Baseline to 2 weeks', 'description': 'Cure: Disappearance of all pre-treatment signs and symptoms of infection; Improvement: Improvement in, or partial disappearance of signs and symptoms without requiring further antibacterial therapy. Subjects who discontinued study drug for reasons other than lack of clinical response, i.e., despite clinical improvement, were included in this category; and Failure: No change in, or worsening of baseline signs and symptoms requiring modification of treatment, ie, addition of or switch to another systemic antibacterial therapy. An unknown response or missing value was considered clinical failure.'}], 'secondaryOutcomes': [{'measure': 'Cost (in Indian Rupees) Per Participant of Utilizations Including General Consultations, Medications, Chest X-ray, Complete Blood Count, and Erythrocyte Sedimentation Rate', 'timeFrame': 'Baseline to 3 months', 'description': 'Cost (in Indian Rupees) per participant of utilizations including general consultations over the study; each medication over the study (study drug, analgesics, antipyretics, anti-inflammatory drugs, vitamins, other study medication), radiological tests over the study (chest X-ray); and clinical laboratory tests over the study (complete blood count and erythrocyte sedimentation rate).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['TRULIMAX (AZITHROMYCIN ) NON-INTERVENTIONAL STUDY'], 'conditions': ['Upper Respiratory Tract Infections']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0661198&StudyName=Trulimax%20%28Azithromycin%20%29%20Non-Interventional%20Study%20In%20Acute%20Bacterial%20Upper%20Respiratory%20Tract%20Infections', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'To assess effectiveness of Trulimax (Azithromycin) in Acute Bacterial Upper Respiratory Tract Infections (URTIs).', 'detailedDescription': 'Prospective, Open-label, Non-interventional and Multi-center Study NA'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Only patients with acute URTI, presumed to be of bacterial origin as per the clinical judgment of the investigator will be enrolled in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.\n* Patients with acute URTI, presumed to be of bacterial origin as per the clinical judgment of the investigator.\n\nExclusion Criteria:\n\nN/A'}, 'identificationModule': {'nctId': 'NCT00827502', 'briefTitle': 'Trulimax (Azithromycin ) Non-Interventional Study In Acute Bacterial Upper Respiratory Tract Infections', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Trulimax (Azithromycin ) Non-Interventional Study In Acute Bacterial Upper Respiratory Tract Infections', 'orgStudyIdInfo': {'id': 'A0661198'}}, 'contactsLocationsModule': {'locations': [{'zip': '530001', 'city': 'Jn Vishakhapatnam', 'state': 'Andhra Pradesh', 'country': 'India', 'facility': 'Pfizer Investigational Site'}, {'zip': '530 020', 'city': 'Visakhapatnam', 'state': 'Andhra Pradesh', 'country': 'India', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 17.68009, 'lon': 83.20161}}, {'zip': '781 011', 'city': 'Guwhati', 'state': 'Assam', 'country': 'India', 'facility': 'Pfizer Investigational Site'}, {'zip': '440 009', 'city': 'Nagpur', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 21.14631, 'lon': 79.08491}}, {'zip': '400 075', 'city': 'Vāshi', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 18.75013, 'lon': 73.04189}}, {'zip': '110 057', 'city': 'New Delhi', 'state': 'National Capital Territory of Delhi', 'country': 'India', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'zip': '110060', 'city': 'New Delhi', 'state': 'National Capital Territory of Delhi', 'country': 'India', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'zip': '110085', 'city': 'Delhi', 'state': 'New Delhi', 'country': 'India', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 28.65195, 'lon': 77.23149}}, {'zip': '600 084', 'city': 'Chennai', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'zip': '602 001', 'city': 'Chennai', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'zip': '226020', 'city': 'Lucknow', 'state': 'Uttar Pradesh', 'country': 'India', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 26.83928, 'lon': 80.92313}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Director, Clinical Trial Disclosure Group', 'oldOrganization': 'Pfizer, Inc.'}}}}