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Completed

NCT Number: NCT00871494

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

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.

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Key information

Conditions

Pelvic Inflammatory Disease Adnexal Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Pelvic Infection Urogenital Diseases

Age range

16 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Aichi-gun, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Azithromycin

Drug

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 30, 2009
Registry last updated
Nov 3, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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