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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multicenter, Non-Randomized, Open Label Study Of Azithromycin Intravenous Followed By Oral Administration In Japanese Adult Subjects With Pelvic Inflammatory Disease (PI

Brief Summary: 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.

Detailed Summary:
Sponsor: Pfizer

Current Primary Outcome: 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 ]

Original Primary Outcome: The clinical efficacy assessed by Data Review Committee. [ Time Frame: Day 15 ]

Current Secondary Outcome:

• 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.

• 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.

• 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.

Original Secondary Outcome:

• Data Review Committee's clinical efficacy. [ Time Frame: End of treatment, Day 29 ]
• Investigator's clinical efficacy. [ Time Frame: End of treatment, Day 15, Day 29 ]
• Data Review Committee's bacteriologic efficacy. [ Time Frame: End of treatment, Day 15, Day 29 ]
• Investigator's bacteriologic efficacy. [ Time Frame: Investigator's bacteriologic efficacy, Day 15, Day 29 ]

Information By: Pfizer

Dates:
Date Received: March 27, 2009
Date Started: May 2009
Date Completion:
Last Updated: September 28, 2011
Last Verified: September 2011