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

May 19, 2008 updated by: Pfizer

A Multicenter, Non-Randomized, Open Label Trial Of Azithromycin SR For The Treatment Of Mild To Moderate Community Acquired Pneumonia In Japanese Adults

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

153

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Fukuoka, Japan, 810-0053
        • Pfizer Investigational Site
      • Fukuoka, Japan, 813-0031
        • Pfizer Investigational Site
      • Fukuoka, Japan, 813-0034
        • Pfizer Investigational Site
      • Oita, Japan, 870-0263
        • Pfizer Investigational Site
      • Oita, Japan, 870-0921
        • Pfizer Investigational Site
      • Oita, Japan, 870-8511
        • Pfizer Investigational Site
      • Okinawa, Japan, 904-2195
        • Pfizer Investigational Site
      • Yamagata, Japan, 990-8545
        • Pfizer Investigational Site
    • Chiba
      • Asahi, Chiba, Japan, 289-2511
        • Pfizer Investigational Site
    • Fukuoka
      • Higashi, Fukuoka, Japan, 812-0053
        • Pfizer Investigational Site
      • Kasuya-gun, Fukuoka, Japan, 811-2122
        • Pfizer Investigational Site
      • Munakata, Fukuoka, Japan, 811-3431
        • Pfizer Investigational Site
      • Nishi-ku, Fukuoka, Japan, 819-8555
        • Pfizer Investigational Site
    • Gunma
      • Isesaki, Gunma, Japan, 372-0817
        • Pfizer Investigational Site
      • Maebashi, Gunma, Japan, 371-0014
        • Pfizer Investigational Site
    • Hokkaido
      • Asahikawa, Hokkaido, Japan, 070-0038
        • Pfizer Investigational Site
      • Asahikawa, Hokkaido, Japan, 070-8012
        • Pfizer Investigational Site
      • Asahikawa, Hokkaido, Japan, 071-8133
        • Pfizer Investigational Site
      • Asahikawa, Hokkaido, Japan, 078-8261
        • Pfizer Investigational Site
      • Kamikawa-gun, Hokkaido, Japan, 071-1521
        • Pfizer Investigational Site
      • Sapporo, Hokkaido, Japan, 004-0022
        • Pfizer Investigational Site
      • Teine, Hokkaido, Japan, 006-0032
        • Pfizer Investigational Site
    • Ibaraki
      • Hitachi, Ibaraki, Japan, 317-0077
        • Pfizer Investigational Site
      • Hitachinaka, Ibaraki, Japan, 312-0057
        • Pfizer Investigational Site
      • Kasama, Ibaraki, Japan, 309-1793
        • Pfizer Investigational Site
      • Moriya, Ibaraki, Japan, 302-0118
        • Pfizer Investigational Site
      • Toride, Ibaraki, Japan, 302-0005
        • Pfizer Investigational Site
      • Tsuchiura, Ibaraki, Japan, 300-0053
        • Pfizer Investigational Site
    • Kagawa
      • Marugame, Kagawa, Japan, 763-0013
        • Pfizer Investigational Site
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 232-0021
        • Pfizer Investigational Site
    • Kangawa
      • Yokosuka, Kangawa, Japan, 239-0821
        • Pfizer Investigational Site
    • Nagasaki
      • Emukae, Kitamatsuura, Nagasaki, Japan, 859-6131
        • Pfizer Investigational Site
      • Hirase-cho, Sasebo,, Nagasaki, Japan, 857-8511
        • Pfizer Investigational Site
      • Nagasaki-city, Nagasaki, Japan, 852-8501
        • Pfizer Investigational Site
      • Shigesato-cho, Nagasaki, Nagasaki, Japan, 852-8511
        • Pfizer Investigational Site
    • Oita
      • Ohte-machi, Oita city, Oita, Japan, 870-0022
        • Pfizer Investigational Site
      • Oita City, Oita, Oita, Japan, 870-0161
        • Pfizer Investigational Site
      • Tanaka-machi, Oita, Oita, Japan, 870-0852
        • Pfizer Investigational Site
      • Yufu, Oita, Japan, 879-5593
        • Pfizer Investigational Site
    • Okinawa
      • Naha, Okinawa, Japan, 901-0152
        • Pfizer Investigational Site
      • Nakagami-gun, Okinawa, Japan, 903-0215
        • Pfizer Investigational Site
      • Shimajiri-gun, Okinawa, Japan, 901-1303
        • Pfizer Investigational Site
    • Osaka
      • Daito, Osaka, Japan, 574-0014
        • Pfizer Investigational Site
      • Katano, Osaka, Japan, 576-0016
        • Pfizer Investigational Site
      • Kita-ku, Osaka, Japan, 530-0004
        • Pfizer Investigational Site
    • Saitama
      • Koshigaya, Saitama, Japan, 343-0807
        • Pfizer Investigational Site
    • Tokyo
      • Kiyose, Tokyo, Japan, 204-0022
        • Pfizer Investigational Site
      • Nakano, Tokyo, Japan, 164-0012
        • Pfizer Investigational Site
      • Oume,, Tokyo, Japan, 198-0021
        • Pfizer Investigational Site
      • Setagaya, Tokyo, Japan, 158-0095
        • Pfizer Investigational Site
      • Setagaya, Tokyo, Japan, 157-0061
        • Pfizer Investigational Site
      • Shinagawa, Tokyo, Japan, 140-0011
        • Pfizer Investigational Site
      • Sumida, Tokyo, Japan, 131-0043
        • Pfizer Investigational Site
    • Yamagata
      • Yonezawa, Yamagata, Japan, 992-0045
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary endpoint is Data Review Committee's Clinical efficacy at Day 8.

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

August 3, 2006

First Submitted That Met QC Criteria

August 3, 2006

First Posted (Estimate)

August 4, 2006

Study Record Updates

Last Update Posted (Estimate)

May 20, 2008

Last Update Submitted That Met QC Criteria

May 19, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A0661174

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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