Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2026-03-09 @ 4:05 AM
Study NCT ID:
NCT00643734
Status:
COMPLETED
Last Update Posted:
2008-03-26
First Post:
2008-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Mild to Moderate Pneumonia in Adult Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064704', 'term': 'Levofloxacin'}], 'ancestors': [{'id': 'D015242', 'term': 'Ofloxacin'}, {'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 468}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-03', 'completionDateStruct': {'date': '2004-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-03-19', 'studyFirstSubmitDate': '2008-03-19', 'studyFirstSubmitQcDate': '2008-03-19', 'lastUpdatePostDateStruct': {'date': '2008-03-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sponsor assessment of clinical response (cure or failure) in the Clinical Per Protocol population', 'timeFrame': 'Test of Cure (TOC) visit (Days 14-21)'}], 'secondaryOutcomes': [{'measure': 'laboratory abnormalities', 'timeFrame': 'Baseline and TOC visit'}, {'measure': 'sponsor assessment of clinical response (cure or failure) in the remaining study populations', 'timeFrame': 'EOT visit and TOC visit'}, {'measure': 'sponsor assessment of clinical response by baseline pathogen for the Bacteriological Per Protocol population', 'timeFrame': 'EOT visit and TOC visit'}, {'measure': 'investigator assessment of clinical response (cure or failure) in the Clinical Per Protocol population', 'timeFrame': 'TOC visit'}, {'measure': 'sponsor assessment of clinical response (cure or failure) in the Clinical Per Protocol population', 'timeFrame': 'End of Treatment (EOT) visit (Days 8-11)'}, {'measure': 'bacteriological response on a per pathogen basis for the Bacteriological Per Protocol population', 'timeFrame': 'TOC visit'}, {'measure': 'sponsor assessment of clinical response (cure or failure) in the Clinical Per Protocol population', 'timeFrame': 'Long-Term Follow-Up (LTFU) visit (Days 28-35)'}, {'measure': 'summary of baseline susceptibilities', 'timeFrame': 'Study endpoint'}, {'measure': 'adverse events', 'timeFrame': 'Continuous'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pneumonia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0661103&StudyName=A%20Multicenter%2C%20Randomized%2C%20Double-Blind%2C%20Double-Dummy%20Trial%20of%20Azithromycin%20SR%20Compared%20With%20Levofloxacin%20for%20the%20Treatment%20of%20Mild%20to', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The study was performed to see if a single, 2.0-g oral dose of azithromycin sustained release (SR) was at least as effective as a 7-day regimen of levofloxacin (500 mg once daily) for the treatment of mild to moderate community-acquired pneumonia, and to assess the efficacy and safety of both treatment regimens.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with clinical evidence of mild to moderate community-acquired pneumonia, including cough productive of sputum and a diagnosis of pneumonia, were included.\n\nExclusion Criteria:\n\nKey exclusion criteria were treatment with any systemic antibiotic of greater than one dose or one combination dose within the previous 7 days, previously diagnosed conditions which tend to mimic or complicate the course and the evaluation of the evaluation process (e.g., bronchiectasis, lung abscess or empyema, active tuberculosis, pulmonary malignancy, cystic fibrosis, post-obstructive pneumonia), hospitalization in the previous 14 days or infection acquired in the hospital, and residents of a long-term care facility.'}, 'identificationModule': {'nctId': 'NCT00643734', 'briefTitle': 'A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR 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