Clinical trial NCT00871494: Study Of Azithromycin Intravenous Formulation Against Pelvic Inflammatory Disease (PID) In Japan
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pelvic Inflammatory Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-03-30
Enrollment: 76
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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).

Primary outcomes:
measure: 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)
timeFrame: End of Treatment, Day 15 and Day 29
Secondary outcomes:
measure: Response Rate (Clinical Response, Investigator Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option)
timeFrame: End of Treatment, Day 15 and Day 29
measure: 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)
timeFrame: End of treatment, Day 15, Day 29
measure: Eradication Rate (Bacteriological Response, Investigator Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option)
timeFrame: End of treatment, Day 15, Day 29
Other outcomes:
Locations:
city: Nagoya-city Naka-ku
country: Japan
facility: Pfizer Investigational Site
state: Aichi-prefecture
city: Tanba-gun Fusou-chou
country: Japan
facility: Pfizer Investigational Site
state: Aichi-prefecture
city: Aichi-gun
country: Japan
facility: Pfizer Investigational Site
state: Aichi
city: Ichinomiya
country: Japan
facility: Pfizer Investigational Site
state: Aichi
city: Hirosaki-city
country: Japan
facility: Pfizer Investigational Site
state: Aomori-prefecture
city: Niihama-city
country: Japan
facility: Pfizer Investigational Site
state: Ehime
city: Niihama
country: Japan
facility: Pfizer Investigational Site
state: Ehime
city: Chuou-ku
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka-city
city: Kitakyushu-shi, Yahatanishi-ku
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka-ken
city: Kasuga-city
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka-prefecture
city: Kitakyusyu
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
city: Takasaki-shi
country: Japan
facility: Pfizer Investigational Site
state: Gunma-ken
city: Takasaki-city
country: Japan
facility: Pfizer Investigational Site
state: Gunma-prefecture
city: Hakodate-shi Goryoukaku-cho
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Hakodate-shi Hon-cho
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Chuo-ku
country: Japan
facility: Pfizer Investigational Site
state: Hyogo
city: Kobe
country: Japan
facility: Pfizer Investigational Site
state: Hyogo
city: Kounoike shinmachi
country: Japan
facility: Pfizer Investigational Site
state: Kagoshima-city
city: Kamigyou-ku
country: Japan
facility: Pfizer Investigational Site
state: Kyoto-city
city: Suzaka-shi
country: Japan
facility: Pfizer Investigational Site
state: Nagano-ken
city: Okayama-shi
country: Japan
facility: Pfizer Investigational Site
state: Okayama-ken
city: Koshigaya
country: Japan
facility: Pfizer Investigational Site
state: Saitama
city: Aoba-ku
country: Japan
facility: Pfizer Investigational Site
state: Sendai-city
city: Meguro-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Minato-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Naka-ku
country: Japan
facility: Pfizer Investigational Site
state: Yokohama-city Kanagawa
city: Fukushima
country: Japan
facility: Pfizer Investigational Site
city: Kagoshima
country: Japan
facility: Pfizer Investigational Site
city: Nagano
country: Japan
facility: Pfizer Investigational Site
city: Okayama-city
country: Japan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.