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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00871494
First received: March 27, 2009
Last updated: September 28, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Pelvic Inflammatory Disease
Drug: Azithromycin
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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.



Enrollment: 76
Study Start Date: May 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   16 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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).

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00871494

Locations
Japan
Pfizer Investigational Site
Nagoya-city Naka-ku, Aichi-prefecture, Japan
Pfizer Investigational Site
Tanba-gun Fusou-chou, Aichi-prefecture, Japan
Pfizer Investigational Site
Aichi-gun, Aichi, Japan
Pfizer Investigational Site
Ichinomiya, Aichi, Japan
Pfizer Investigational Site
Hirosaki-city, Aomori-prefecture, Japan
Pfizer Investigational Site
Niihama, Ehime, Japan
Pfizer Investigational Site
Niihama-city, Ehime, Japan
Pfizer Investigational Site
Chuou-ku, Fukuoka-city, Japan
Pfizer Investigational Site
Kitakyushu-shi, Yahatanishi-ku, Fukuoka-ken, Japan
Pfizer Investigational Site
Kasuga-city, Fukuoka-prefecture, Japan
Pfizer Investigational Site
Kitakyusyu, Fukuoka, Japan
Pfizer Investigational Site
Takasaki-shi, Gunma-ken, Japan
Pfizer Investigational Site
Takasaki-city, Gunma-prefecture, Japan
Pfizer Investigational Site
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
Chuo-ku, Hyogo, Japan
Pfizer Investigational Site
Kobe, Hyogo, Japan
Pfizer Investigational Site
Kounoike shinmachi, Kagoshima-city, Japan
Pfizer Investigational Site
Kamigyou-ku, Kyoto-city, Japan
Pfizer Investigational Site
Suzaka-shi, Nagano-ken, Japan
Pfizer Investigational Site
Okayama-shi, Okayama-ken, Japan
Pfizer Investigational Site
Koshigaya, Saitama, Japan
Pfizer Investigational Site
Aoba-ku, Sendai-city, Japan
Pfizer Investigational Site
Meguro-ku, Tokyo, Japan
Pfizer Investigational Site
Minato-ku, Tokyo, Japan
Pfizer Investigational Site
Naka-ku, Yokohama-city Kanagawa, Japan
Pfizer Investigational Site
Fukushima, Japan
Pfizer Investigational Site
Kagoshima, Japan
Pfizer Investigational Site
Nagano, Japan
Pfizer Investigational Site
Okayama-city, Japan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00871494     History of Changes
Other Study ID Numbers: A0661192
Study First Received: March 27, 2009
Results First Received: September 28, 2011
Last Updated: September 28, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Pelvic Inflammatory Disease
Pelvic Infection
Infection
Adnexal Diseases
Genital Diseases, Female
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014