Study Of Azithromycin Intravenous Formulation Against Pelvic Inflammatory Disease (PID) In Japan
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
1 other identifier
interventional
76
1 country
31
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started May 2009
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2009
CompletedFirst Posted
Study publicly available on registry
March 30, 2009
CompletedStudy Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedResults Posted
Study results publicly available
November 3, 2011
CompletedNovember 3, 2011
September 1, 2011
1.5 years
March 27, 2009
September 28, 2011
September 28, 2011
Conditions
Outcome Measures
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)
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 Outcomes (3)
Response Rate (Clinical Response, Investigator Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option)
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)
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)
End of treatment, Day 15, Day 29
Study Arms (1)
Azithromycin switch therapy (switch from intravenous to oral).
EXPERIMENTALInterventions
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 Criteria
You may qualify if:
- 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).
You may not qualify if:
- Known or suspected hypersensitivity or intolerance to azithromycin, other macrolides, or ketolides.
- Hepatic dysfunction (AST, ALT, total bilirubin \> 3 times institutional normal).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (31)
Pfizer Investigational Site
Aichi-gun, Aichi-ken, Japan
Pfizer Investigational Site
Ichinomiya, Aichi-ken, Japan
Pfizer Investigational Site
Nagoya-city Naka-ku, Aichi-ken, Japan
Pfizer Investigational Site
Tanba-gun Fusou-chou, Aichi-ken, Japan
Pfizer Investigational Site
Hirosaki, Aomori, Japan
Pfizer Investigational Site
Niihama, Ehime, Japan
Pfizer Investigational Site
Kasuga, Fukuoka, Japan
Pfizer Investigational Site
Kitakyushu, Fukuoka, Japan
Pfizer Investigational Site
Kitakyushu-shi, Yahatanishi-ku, Fukuoka, Japan
Pfizer Investigational Site
Chuou-ku, Fukuoka-city, Japan
Pfizer Investigational Site
Fukushima, Fukushima, Japan
Pfizer Investigational Site
Takasaki, Gunma, Japan
Pfizer Investigational Site
Takasaki-shi, Gunma, Japan
Pfizer Investigational Site
Hakodate-shi Goryoukaku-cho, Hokkaido, Japan
Pfizer Investigational Site
Hakodate-shi Hon-cho, Hokkaido, Japan
Pfizer Investigational Site
Sapporo, Hokkaido, Japan
Pfizer Investigational Site
Chuo-ku, Hyōgo, Japan
Pfizer Investigational Site
Kobe, Hyōgo, Japan
Pfizer Investigational Site
Kounoike Shinmachi, Kagoshima-city, Japan
Pfizer Investigational Site
Kagoshima, Kagoshima-ken, Japan
Pfizer Investigational Site
Kamigyou-ku, Kyoto-city, Japan
Pfizer Investigational Site
Nagano, Nagano, Japan
Pfizer Investigational Site
Suzaka-shi, Nagano, Japan
Pfizer Investigational Site
Okayama, Okayama-city, Japan
Pfizer Investigational Site
Okayama, 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
Nakaku, Yokohama-city Kanagawa, Japan
Pfizer Investigational Site
Fukushima, Japan
Related Publications (1)
Mikamo H, Iwasaku K, Yamagishi Y, Matsumizu M, Nagashima M. Efficacy and safety of intravenous azithromycin followed by oral azithromycin for the treatment of acute pelvic inflammatory disease and perihepatitis in Japanese women. J Infect Chemother. 2014 Jul;20(7):429-35. doi: 10.1016/j.jiac.2014.04.001. Epub 2014 Apr 29.
PMID: 24787738DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2009
First Posted
March 30, 2009
Study Start
May 1, 2009
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
November 3, 2011
Results First Posted
November 3, 2011
Record last verified: 2011-09