search
Back to results

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

Primary Purpose

Pneumonia, Community-Acquired

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Azithromycin SR
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia, Community-Acquired

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)).

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 3, 2006
Last Updated
May 19, 2008
Sponsor
Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT00360295
Brief Title
A Trial Of Azithromycin SR For The Treatment Of Mild To Moderate Community Acquired Pneumonia In Japanese Adults
Official Title
A Multicenter, Non-Randomized, Open Label Trial Of Azithromycin SR For The Treatment Of Mild To Moderate Community Acquired Pneumonia In Japanese Adults
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Community-Acquired

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
153 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Azithromycin SR
Primary Outcome Measure Information:
Title
The primary endpoint is Data Review Committee's Clinical efficacy at Day 8.
Secondary Outcome Measure Information:
Title
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)
Title
Adverse events and safety Laboratory data

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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)).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Asahi
State/Province
Chiba
ZIP/Postal Code
289-2511
Country
Japan
Facility Name
Pfizer Investigational Site
City
Higashi
State/Province
Fukuoka
ZIP/Postal Code
812-0053
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kasuya-gun
State/Province
Fukuoka
ZIP/Postal Code
811-2122
Country
Japan
Facility Name
Pfizer Investigational Site
City
Munakata
State/Province
Fukuoka
ZIP/Postal Code
811-3431
Country
Japan
Facility Name
Pfizer Investigational Site
City
Nishi-ku
State/Province
Fukuoka
ZIP/Postal Code
819-8555
Country
Japan
Facility Name
Pfizer Investigational Site
City
Isesaki
State/Province
Gunma
ZIP/Postal Code
372-0817
Country
Japan
Facility Name
Pfizer Investigational Site
City
Maebashi
State/Province
Gunma
ZIP/Postal Code
371-0014
Country
Japan
Facility Name
Pfizer Investigational Site
City
Asahikawa
State/Province
Hokkaido
ZIP/Postal Code
070-0038
Country
Japan
Facility Name
Pfizer Investigational Site
City
Asahikawa
State/Province
Hokkaido
ZIP/Postal Code
070-8012
Country
Japan
Facility Name
Pfizer Investigational Site
City
Asahikawa
State/Province
Hokkaido
ZIP/Postal Code
071-8133
Country
Japan
Facility Name
Pfizer Investigational Site
City
Asahikawa
State/Province
Hokkaido
ZIP/Postal Code
078-8261
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kamikawa-gun
State/Province
Hokkaido
ZIP/Postal Code
071-1521
Country
Japan
Facility Name
Pfizer Investigational Site
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
004-0022
Country
Japan
Facility Name
Pfizer Investigational Site
City
Teine
State/Province
Hokkaido
ZIP/Postal Code
006-0032
Country
Japan
Facility Name
Pfizer Investigational Site
City
Hitachinaka
State/Province
Ibaraki
ZIP/Postal Code
312-0057
Country
Japan
Facility Name
Pfizer Investigational Site
City
Hitachi
State/Province
Ibaraki
ZIP/Postal Code
317-0077
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kasama
State/Province
Ibaraki
ZIP/Postal Code
309-1793
Country
Japan
Facility Name
Pfizer Investigational Site
City
Moriya
State/Province
Ibaraki
ZIP/Postal Code
302-0118
Country
Japan
Facility Name
Pfizer Investigational Site
City
Toride
State/Province
Ibaraki
ZIP/Postal Code
302-0005
Country
Japan
Facility Name
Pfizer Investigational Site
City
Tsuchiura
State/Province
Ibaraki
ZIP/Postal Code
300-0053
Country
Japan
Facility Name
Pfizer Investigational Site
City
Marugame
State/Province
Kagawa
ZIP/Postal Code
763-0013
Country
Japan
Facility Name
Pfizer Investigational Site
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
232-0021
Country
Japan
Facility Name
Pfizer Investigational Site
City
Yokosuka
State/Province
Kangawa
ZIP/Postal Code
239-0821
Country
Japan
Facility Name
Pfizer Investigational Site
City
Emukae, Kitamatsuura
State/Province
Nagasaki
ZIP/Postal Code
859-6131
Country
Japan
Facility Name
Pfizer Investigational Site
City
Hirase-cho, Sasebo,
State/Province
Nagasaki
ZIP/Postal Code
857-8511
Country
Japan
Facility Name
Pfizer Investigational Site
City
Nagasaki-city
State/Province
Nagasaki
ZIP/Postal Code
852-8501
Country
Japan
Facility Name
Pfizer Investigational Site
City
Shigesato-cho, Nagasaki
State/Province
Nagasaki
ZIP/Postal Code
852-8511
Country
Japan
Facility Name
Pfizer Investigational Site
City
Ohte-machi, Oita city
State/Province
Oita
ZIP/Postal Code
870-0022
Country
Japan
Facility Name
Pfizer Investigational Site
City
Oita City, Oita
State/Province
Oita
ZIP/Postal Code
870-0161
Country
Japan
Facility Name
Pfizer Investigational Site
City
Tanaka-machi, Oita
State/Province
Oita
ZIP/Postal Code
870-0852
Country
Japan
Facility Name
Pfizer Investigational Site
City
Yufu
State/Province
Oita
ZIP/Postal Code
879-5593
Country
Japan
Facility Name
Pfizer Investigational Site
City
Naha
State/Province
Okinawa
ZIP/Postal Code
901-0152
Country
Japan
Facility Name
Pfizer Investigational Site
City
Nakagami-gun
State/Province
Okinawa
ZIP/Postal Code
903-0215
Country
Japan
Facility Name
Pfizer Investigational Site
City
Shimajiri-gun
State/Province
Okinawa
ZIP/Postal Code
901-1303
Country
Japan
Facility Name
Pfizer Investigational Site
City
Daito
State/Province
Osaka
ZIP/Postal Code
574-0014
Country
Japan
Facility Name
Pfizer Investigational Site
City
Katano
State/Province
Osaka
ZIP/Postal Code
576-0016
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kita-ku
State/Province
Osaka
ZIP/Postal Code
530-0004
Country
Japan
Facility Name
Pfizer Investigational Site
City
Koshigaya
State/Province
Saitama
ZIP/Postal Code
343-0807
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kiyose
State/Province
Tokyo
ZIP/Postal Code
204-0022
Country
Japan
Facility Name
Pfizer Investigational Site
City
Nakano
State/Province
Tokyo
ZIP/Postal Code
164-0012
Country
Japan
Facility Name
Pfizer Investigational Site
City
Oume,
State/Province
Tokyo
ZIP/Postal Code
198-0021
Country
Japan
Facility Name
Pfizer Investigational Site
City
Setagaya
State/Province
Tokyo
ZIP/Postal Code
157-0061
Country
Japan
Facility Name
Pfizer Investigational Site
City
Setagaya
State/Province
Tokyo
ZIP/Postal Code
158-0095
Country
Japan
Facility Name
Pfizer Investigational Site
City
Shinagawa
State/Province
Tokyo
ZIP/Postal Code
140-0011
Country
Japan
Facility Name
Pfizer Investigational Site
City
Sumida
State/Province
Tokyo
ZIP/Postal Code
131-0043
Country
Japan
Facility Name
Pfizer Investigational Site
City
Yonezawa
State/Province
Yamagata
ZIP/Postal Code
992-0045
Country
Japan
Facility Name
Pfizer Investigational Site
City
Fukuoka
ZIP/Postal Code
810-0053
Country
Japan
Facility Name
Pfizer Investigational Site
City
Fukuoka
ZIP/Postal Code
813-0031
Country
Japan
Facility Name
Pfizer Investigational Site
City
Fukuoka
ZIP/Postal Code
813-0034
Country
Japan
Facility Name
Pfizer Investigational Site
City
Oita
ZIP/Postal Code
870-0263
Country
Japan
Facility Name
Pfizer Investigational Site
City
Oita
ZIP/Postal Code
870-0921
Country
Japan
Facility Name
Pfizer Investigational Site
City
Oita
ZIP/Postal Code
870-8511
Country
Japan
Facility Name
Pfizer Investigational Site
City
Okinawa
ZIP/Postal Code
904-2195
Country
Japan
Facility Name
Pfizer Investigational Site
City
Yamagata
ZIP/Postal Code
990-8545
Country
Japan

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0661174&StudyName=A%20Trial%20Of%20Azithromycin%20SR%20For%20The%20Treatment%20Of%20Mild%20To%20Moderate%20Community%20Acquired%20Pneumonia%20In%20Japan%20Adults
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

We'll reach out to this number within 24 hrs