Study Of Azithromycin Intravenous Formulation Against Pelvic Inflammatory Disease (PID) In Japan

September 28, 2011 updated by: Pfizer

A Multicenter, Non-Randomized, Open Label Study Of Azithromycin Intravenous Followed By Oral Administration In Japanese Adult Subjects With Pelvic Inflammatory Disease (PID) Requiring Initial Intravenous Therapy

Azithromycin had a potent in vitro activities and broad spectrum from typical and atypical bacteria to anaerobes. Azithromycin intravenous formulation demonstrated high efficacy and eradication rate in the western clinical trials. Development of azithromycin intravenous formulation would bring the clinical benefit to patients with pelvic inflammatory disease (PID) in Japan.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

76

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
      • Fukushima, Japan
        • Pfizer Investigational Site
      • Kagoshima, Japan
        • Pfizer Investigational Site
      • Nagano, Japan
        • Pfizer Investigational Site
      • Okayama-city, Japan
        • Pfizer Investigational Site
    • Aichi
      • Aichi-gun, Aichi, Japan
        • Pfizer Investigational Site
      • Ichinomiya, Aichi, Japan
        • Pfizer Investigational Site
    • Aichi-prefecture
      • Nagoya-city Naka-ku, Aichi-prefecture, Japan
        • Pfizer Investigational Site
      • Tanba-gun Fusou-chou, Aichi-prefecture, Japan
        • Pfizer Investigational Site
    • Aomori-prefecture
      • Hirosaki-city, Aomori-prefecture, Japan
        • Pfizer Investigational Site
    • Ehime
      • Niihama, Ehime, Japan
        • Pfizer Investigational Site
      • Niihama-city, Ehime, Japan
        • Pfizer Investigational Site
    • Fukuoka
      • Kitakyusyu, Fukuoka, Japan
        • Pfizer Investigational Site
    • Fukuoka-city
      • Chuou-ku, Fukuoka-city, Japan
        • Pfizer Investigational Site
    • Fukuoka-ken
      • Kitakyushu-shi, Yahatanishi-ku, Fukuoka-ken, Japan
        • Pfizer Investigational Site
    • Fukuoka-prefecture
      • Kasuga-city, Fukuoka-prefecture, Japan
        • Pfizer Investigational Site
    • Gunma-ken
      • Takasaki-shi, Gunma-ken, Japan
        • Pfizer Investigational Site
    • Gunma-prefecture
      • Takasaki-city, Gunma-prefecture, Japan
        • Pfizer Investigational Site
    • Hokkaido
      • Hakodate-shi Goryoukaku-cho, Hokkaido, Japan
        • Pfizer Investigational Site
      • Hakodate-shi Hon-cho, Hokkaido, Japan
        • Pfizer Investigational Site
      • Sapporo-shi, Hokkaido, Japan
        • Pfizer Investigational Site
    • Hyogo
      • Chuo-ku, Hyogo, Japan
        • Pfizer Investigational Site
      • Kobe, Hyogo, Japan
        • Pfizer Investigational Site
    • Kagoshima-city
      • Kounoike shinmachi, Kagoshima-city, Japan
        • Pfizer Investigational Site
    • Kyoto-city
      • Kamigyou-ku, Kyoto-city, Japan
        • Pfizer Investigational Site
    • Nagano-ken
      • Suzaka-shi, Nagano-ken, Japan
        • Pfizer Investigational Site
    • Okayama-ken
      • Okayama-shi, Okayama-ken, Japan
        • Pfizer Investigational Site
    • Saitama
      • Koshigaya, Saitama, Japan
        • Pfizer Investigational Site
    • Sendai-city
      • Aoba-ku, Sendai-city, Japan
        • Pfizer Investigational Site
    • Tokyo
      • Meguro-ku, Tokyo, Japan
        • Pfizer Investigational Site
      • Minato-ku, Tokyo, Japan
        • Pfizer Investigational Site
    • Yokohama-city Kanagawa
      • Naka-ku, Yokohama-city Kanagawa, 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

Female

Description

Inclusion Criteria:

Both of following symptoms should be observed.

  • Lower abdominal pain and/or lower abdominal tenderness.
  • Hypochondrial pain and/or hypochondrial tenderness (tenderness of uterus or adnexa of uterus).

Exclusion Criteria:

Known or suspected hypersensitivity or intolerance to azithromycin, other macrolides, or ketolides.

Hepatic dysfunction (AST, ALT, total bilirubin > 3 times institutional normal).

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 switch therapy (switch from intravenous to oral).
Drug: Azithromycin
The patients will receive 500 mg intravenous azithromycin QD for 1 to 2 days. The period of administration of intravenous dosing is judged by investigators according to patient status. Following intravenous administration, the patients will be received the 250 mg oral azithromycin (tablet formulation) QD to complete a total of 7 days therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response Rate (Clinical Response, Data Review Committee Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option)
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.

The inclusion criterion regarding fever was amended from the required criteria to the additional criteria in consultation with the regulatory authority. The subset of participants who were enrolled after the protocol amendment was the primary analysis sets for efficacy.
End of Treatment, Day 15 and Day 29

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response Rate (Clinical Response, Investigator Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option)
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.

The inclusion criterion regarding fever was amended from the required criteria to the additional criteria in consultation with the regulatory authority. The subset of participants who were enrolled after the protocol amendment was the primary analysis sets for efficacy.
End of Treatment, Day 15 and Day 29
Eradication Rate (Bacteriological Response, Data Review Committee Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option)
Time Frame: End of treatment, Day 15, Day 29

Eradication Rate was calculated from the following formula, "the number of participants assessed as eradication, presumed eradication and microbial substitution" over "total participants excluding ones assessed as indeterminate" multiplied by 100.

The inclusion criterion regarding fever was amended from the required criteria to the additional criteria in consultation with the regulatory authority. The subset of participants who were enrolled after the protocol amendment was the primary analysis sets for efficacy.
End of treatment, Day 15, Day 29
Eradication Rate (Bacteriological Response, Investigator Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option)
Time Frame: End of treatment, Day 15, Day 29

Eradication Rate was calculated from the following formula, "the number of participants assessed as eradication , presumed eradication and microbial substitution" over "total participants excluding ones assessed as indeterminate" multiplied by 100.

The inclusion criterion regarding fever was amended from the required criteria to the additional criteria in consultation with the regulatory authority. The subset of participants who were enrolled after the protocol amendment was the primary analysis sets for efficacy.
End of treatment, Day 15, 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

May 1, 2009

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

March 27, 2009

First Submitted That Met QC Criteria

March 27, 2009

First Posted (Estimate)

March 30, 2009

Study Record Updates

Last Update Posted (Estimate)

November 3, 2011

Last Update Submitted That Met QC Criteria

September 28, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A0661192

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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