A Trial Of Azithromycin SR For The Treatment Of Mild To Moderate Community Acquired Pneumonia In Japanese Adults

Phase 3

Completed

• Conditions: Pneumonia, Community-Acquired

• Registration Number: NCT00360295
• Lead Sponsor: Pfizer

Brief Summary

To evaluate the clinical efficacy and safety in patients with mild or moderate community-acquired pneumonia receiving a dose of 2 g of azithromycin in the SR formulation.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2006-08-03
• Study First Submitted QC: 2006-08-03
• Study First Posted: 2006-08-04
• Study Start: 2006-09
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Status Verified: 2008-05
• Last Update Submitted: 2008-05-19
• Last Update Posted: 2008-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

Inclusion Criteria

• Patients who were diagnosed as mild or moderate in severity by the classification of pneumonia "Clinical evaluation methods for new antimicrobial agents to treat respiratory infections: Report of the Committee for the Respiratory System, Japan Society of Chemotherapy (established in 2000)".

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Exclusion Criteria

• Severe underlying disease; patients in which drug clinical evaluation is difficult because of confounding diseases. ("Severe" assessed by the Severity of underlying diseases and complications of "Clinical evaluation methods for new antimicrobial agents to treat respiratory infections (draft)" by the Japan Society of Chemotherapy (1997)).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The primary endpoint is Data Review Committee's Clinical efficacy at Day 8.

Secondary Outcome Measures

Name	Time	Method
Data Review Committee's clinical efficacy (at Day 15 and 29) Investigator's clinical efficacy (at Day 8, 15 and 29), and the tendency toward clinical improvement (at Day 4) Bacteriological efficacy (at Day 4, 8, 15 and 29)
Adverse events and safety Laboratory data

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇯🇵 Yamagata, Japan