The Study Of Azithromycin Switch Therapy For Treatment Of Community Acquired Pneumonia (CAP)

May 16, 2011 updated by: Pfizer

A Multicenter, Non-Randomized, Open Label Study Of Azithromycin Intravenous Followed By Oral Administration In Japanese Adult Subjects With Community Acquired Pneumonia (CAP) Requiring Initial Intravenous Therapy

Azithromycin has high rates of clinical response and eradication, wide spectrum of activity, so we suppose the development of the azithromycin injectable formulation in Japan would deliver benefit to patients of community acquired pneumonia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

102

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
        • Pfizer Investigational Site
      • Hiroshima, Japan
        • Pfizer Investigational Site
      • Kochi, Japan
        • Pfizer Investigational Site
      • Okinawa, Japan
        • Pfizer Investigational Site
      • Shiogama-city, Japan
        • Pfizer Investigational Site
    • Aichi-ken
      • Seto-shi, Aichi-ken, Japan
        • Pfizer Investigational Site
    • Ehime
      • Touon, Ehime, Japan
        • Pfizer Investigational Site
    • Fukuoka
      • Chikushino, Fukuoka, Japan
        • Pfizer Investigational Site
      • Koga, Fukuoka, Japan
        • Pfizer Investigational Site
      • Yanagawa, Fukuoka, Japan
        • Pfizer Investigational Site
    • Hiroshima
      • Higashihiroshima, Hiroshima, Japan
        • Pfizer Investigational Site
    • Hokkaido
      • Asahikawa, Hokkaido, Japan
        • Pfizer Investigational Site
    • Hyogo
      • Himejishi, Hyogo, Japan
        • Pfizer Investigational Site
    • Ibaraki
      • Moriya-city, Ibaraki, Japan
        • Pfizer Investigational Site
    • Ishikawa
      • Kanazawa, Ishikawa, Japan
        • Pfizer Investigational Site
    • Kagawa
      • Takamatsu, Kagawa, Japan
        • Pfizer Investigational Site
    • Kanagawa
      • Kawasaki-city, Kanagawa, Japan
        • Pfizer Investigational Site
    • Mie
      • Tsu, Mie, Japan
        • Pfizer Investigational Site
    • Miyagi
      • Sendai, Miyagi, Japan
        • Pfizer Investigational Site
    • Nagano
      • Matsumoto, Nagano, Japan
        • Pfizer Investigational Site
    • Nagasaki
      • Emukae, Kitamatsuura, Nagasaki, Japan
        • Pfizer Investigational Site
      • Isahaya, Nagasaki, Japan
        • Pfizer Investigational Site
      • Nagasaki-city, Nagasaki, Japan
        • Pfizer Investigational Site
      • Sasebo City, Nagasaki, Japan
        • Pfizer Investigational Site
    • Niigata-ken
      • Niigata-shi, Niigata-ken, Japan
        • Pfizer Investigational Site
    • Oita
      • Oita City, Oita, Japan
        • Pfizer Investigational Site
      • Yufu, Oita, Japan
        • Pfizer Investigational Site
    • Okayama
      • Kurashiki, Okayama, Japan
        • Pfizer Investigational Site
    • Osaka
      • Sakai, Osaka, Japan
        • Pfizer Investigational Site
    • Sagaken
      • Ureshinoshi, Sagaken, Japan
        • Pfizer Investigational Site
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan
        • Pfizer Investigational Site
    • Tokyo
      • Meguro-Ku, Tokyo, Japan
        • Pfizer Investigational Site
      • Toshima-ku, Tokyo, Japan
        • Pfizer Investigational Site
    • Yamagata
      • Yonezawa, Yamagata, Japan
        • 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:

  • 16 years of age or older patients with CAP.
  • Patients who were diagnosed as moderate in severity.

Exclusion Criteria:

  • Known or suspected hypersensitivity or intolerance to azithromycin, other macrolides, or ketolides.
  • Hepatic dysfunction (AST, ALT, total bilirubin > 3 times institutional normal).
  • Severe renal dysfunction (creatinine clearance < 30 ml/min).
  • Patients who have a history of severe heart diseases (4th -degree of NYHA). Patients who have a congenital or sporadic long QT syndrome, or who are received the drugs with reported QT prolongation.
  • Severe underlying disease.

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)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Azithromycin
Azithromycin switch therapy (switch from intravenous to oral)
Drug: Azithromycin
The intravenous formulation 500 mg is administered once daily for 2-5 days; followed by the oral formulation 500 mg will be given once daily to complete a 7 to 10-day course of therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response Rate (Clinical Response, Data Review Committee Assessment)
Time Frame: End of Treatment, Day 15 and Day 29
Response rate was calculated from the following formula, "the number of participants assessed as effective" over "total participants excluding ones assessed as indeterminate" multiplied by 100.
End of Treatment, Day 15 and Day 29

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response Rate (Clinical Response, Investigator Assessment)
Time Frame: End of Treatment, Day 15 and Day 29
Response rate was calculated from the following formula, "the number of participants assessed as effective" over "total participants excluding ones assessed as indeterminate" multiplied by 100
End of Treatment, Day 15 and Day 29
The Tendency Toward Clinical Improvement (Investigator Assessment)
Time Frame: Day 3
The number of participants who showed tendency toward clinical improvement based on the assessment of temperature, white blood cell count, C-reactive protein, clinical symptoms on Day 3, and was determined to continue the treatment.
Day 3
Eradication Rate (Bacteriological Response, Data Review Committee Assessment)
Time Frame: Day 3, End of Treatment, Day 15 and Day 29
Eradication Rate was calculated from the following formula, "the number of participants assessed as eradication , presumed eradication or microbial substitution" over "total participants excluding ones assessed as indeterminate" multiplied by 100
Day 3, End of Treatment, Day 15 and Day 29
Eradication Rate (Bacteriological Response, Investigator Assessment)
Time Frame: Day 3, End of Treatment, Day 15 and Day 29
Eradication Rate was calculated from the following formula, "the number of participants assessed as eradication , presumed eradication or microbial substitution" over "total participants excluding ones assessed as indeterminate" multiplied by 100
Day 3, End of Treatment, Day 15 and Day 29

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.

General Publications

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

February 1, 2009

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

December 16, 2008

First Submitted That Met QC Criteria

December 16, 2008

First Posted (Estimate)

December 17, 2008

Study Record Updates

Last Update Posted (Estimate)

May 19, 2011

Last Update Submitted That Met QC Criteria

May 16, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A0661191

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.

Clinical Trials on Community Acquired Pneumonia (CAP)

Clinical Trials on Azithromycin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe