Overview

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

Status:
Completed

Trial end date:
2007-05-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Pfizer

Treatments:

Azithromycin

Criteria

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)".

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)).