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

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ClinicalTrials.gov Identifier: NCT00871494
Recruitment Status : Completed
First Posted : March 30, 2009
Results First Posted : November 3, 2011
Last Update Posted : November 3, 2011
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Pelvic Inflammatory Disease Drug: Azithromycin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.



Primary Outcome Measures :
  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 Outcome Measures :
  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.




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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Senior)
Sexes 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).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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-city, Ehime, Japan
Pfizer Investigational Site
Niihama, 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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00871494     History of Changes
Other Study ID Numbers: A0661192
First Posted: March 30, 2009    Key Record Dates
Results First Posted: November 3, 2011
Last Update Posted: November 3, 2011
Last Verified: September 2011

Additional relevant MeSH terms:
Pelvic Inflammatory Disease
Pelvic Infection
Infection
Adnexal Diseases
Genital Diseases, Female