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

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Levofloxacin for the Treatment of Mild to Moderate Community-Acquired Pneumonia in Adults

Conditions
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Pneumonia

Intervention / Treatment
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* Drug: azithromycin sustained release
* Other: placebo
* Drug: levofloxacin
* Other: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with clinical evidence of mild to moderate community-acquired pneumonia, including cough productive of sputum and a diagnosis of pneumonia, were included. Exclusion Criteria: Key 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: azithromycin sustained release<br>* azithromycin SR 2.0 g by mouth in the form of a slurry for 1 dose<br>Other: placebo<br>* placebo<br>|
| Experimental: 2<br> | Drug: levofloxacin<br>* 500 mg (two 250 mg capsules) by mouth once daily for 7 days<br>Other: placebo<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sponsor assessment of clinical response (cure or failure) in the Clinical Per Protocol population |  | Test of Cure (TOC) visit (Days 14-21) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| laboratory abnormalities |  | Baseline and TOC visit | 
| sponsor assessment of clinical response (cure or failure) in the remaining study populations |  | EOT visit and TOC visit | 
| sponsor assessment of clinical response by baseline pathogen for the Bacteriological Per Protocol population |  | EOT visit and TOC visit | 
| investigator assessment of clinical response (cure or failure) in the Clinical Per Protocol population |  | TOC visit | 
| sponsor assessment of clinical response (cure or failure) in the Clinical Per Protocol population |  | End of Treatment (EOT) visit (Days 8-11) | 
| bacteriological response on a per pathogen basis for the Bacteriological Per Protocol population |  | TOC visit | 
| sponsor assessment of clinical response (cure or failure) in the Clinical Per Protocol population |  | Long-Term Follow-Up (LTFU) visit (Days 28-35) | 
| summary of baseline susceptibilities |  | Study endpoint | 
| adverse events |  | Continuous |