A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Clarithromycin Extended Release for the Treatment of Pneumonia in Adult Patients

Study Overview
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Brief Summary
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The study was performed to confirm that a single, 2.0 g oral dose of azithromycin sustained release (SR) at least as effective as 7 days of clarithromycin extended release (ER), 1.0 g by mouth once daily, when used to treat adults with mild to moderate community acquired pneumonia (CAP), and that both treatments were safe.

Official Title
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A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Clarithromycin Extended Release 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: clarithromycin extended release (ER)
* Drug: azithromycin SR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatients with a diagnosis of pneumonia, as demonstrated by a productive cough and at least 2 of the following signs and symptoms: rales and/or evidence of pulmonary consolidation; dyspnea or tachypnea; elevated body temperature; or elevated total peripheral white blood cell count (WBC >10,000/mm3) or greater than 15% immature neutrophils were included. Patients were to have a chest radiograph demonstrating evidence of a new infiltrate or consolidation, and a Modified Fine Risk score of ≤ 70 (Fine Class I and II). Exclusion Criteria: Patients who were treated with any systemic antibiotic of greater than 1 dose or 1 combination dose (such as cephalosporin and macrolide) within the previous 7 days, or the likelihood of receiving other systemic antibiotics during participation in the study; were hospitalized in the previous 14 days or had an infection acquired in the hospital, and who were residents of a long-term care facility were excluded.

Ages Eligible for Study
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Minimum Age: 16 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: clarithromycin extended release (ER)<br>* 7 days of clarithromycin extended release (ER), 1.0 g by mouth once daily<br>|
| Experimental: 2<br> | Drug: azithromycin SR<br>* Single, 2.0 g oral dose of azithromycin sustained release (SR) by mouth once daily<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bacteriologic response (eradication rate) in the Bacteriological Per Protocol population |  | TOC visit | 
| investigator assessment of clinical response in the Clinical Per Protocol population |  | TOC visit | 
| sponsor assessment of clinical response by baseline pathogen |  | End of Treatment (EOT) visit (Day 8-11) and TOC visit | 
| sponsor assessment of clinical response in the non-primary population |  | EOT visit and TOC visit | 
| sponsor assessment of clinical responses in the Clinical Per Protocol population |  | EOT visit and Long-Term Follow-Up (LTFU) visit (Day 28-35) | 
| susceptibilities of baseline pathogens |  | Study endpoint | 
| adverse events |  | Continuous | 
| vital signs |  | Baseline, On-Treatment (OT) visit (Day 3-5), and TOC visit | 
| physical examination |  | Baseline | 
| clinical laboratory assessments (blood chemistry and hematology) |  | Baseline and TOC visit |