Clinical trial NCT01473836: A Phase 3 Study Of Intravenous Metronidazole For Intrabdominal Infection
Official title: A Phase 3, Multicenter, Unblind, Non-Comparative Study To Confirm Efficacy And Safety Of Intravenous Metronidazole In Patients With Intrabdominal Infection In Combination With Intravenous Ceftriaxone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Intra-abdominal Infections
Keywords: Metronidazole
intra-abdominal infection
pelvic inflammatory disease
anaerobe
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-11-17
Enrollment: 38
Sex: ALL
Minimum age (years): 16
Maximum age (years): 79
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the clinical efficacy and safety in Japanese adult subjects with Intra-abdominal/Pelvic infections receiving Metronidazole IV 1,500-2,000 mg/day in combination with ceftriaxone sodium.


Eligibility criteria: Inclusion Criteria:

* 16 years of age or older.
* Diagnosed with intra-abdominal infections or pelvic inflammatory diseases.
* Can be obtained a specimen for bacteriological efficacy assessment.

Exclusion Criteria:

* Known or suspected hypersensitivity, intolerance or contraindication to Metronidazole, Ceftriaxone sodium, or other cephem antibiotics.
* Severe renal dysfunction (creatinine clearance \< 30 mL/min.) Reference: Cockcroft-Gault calculation formula.
* Hepatic dysfunction (AST, ALT, total bilirubin \> 3 times upper limit of normal range values).
* Severe underlying disease; patients in which drug clinical evaluation is difficult because of confounding diseases.

Primary outcomes:
measure: Clinical Response: Response Rate (Data Review Committee Assessment)
timeFrame: Baseline to EOT (up to 14 days), TOC
Secondary outcomes:
measure: Clinical Response: Response Rate (Investigator Assessment)
timeFrame: Baseline to EOT (up to 14 days), TOC
measure: Percentage of Participants Who Was Assessed as Appropriate to Continue Treatment (Investigator Assessment)
timeFrame: Baseline to Day 4
measure: Bacteriological Response: Eradication Rate (Data Review Committee Assessment)
timeFrame: Baseline to Day 4, EOT (up to 14 days), TOC
measure: Bacteriological Response: Eradication Rate (Investigator Assessment)
timeFrame: Baseline to Day 4, EOT (up to 14 days), TOC
measure: Number of Participants Analyzed for Population Pharmacokinetics (PK) of Metronidazole
timeFrame: Four samples were taken at any infusion after the first dosing: during infusion, immediately after end of infusion, between 15 and 60 minutes after end of infusion, and between 2 hours and immediately before the start of the next infusion.
Other outcomes:
Locations:
city: Ichinomiya
country: Japan
facility: Daiyukai First Hospital
state: Aichi
city: Hirosaki
country: Japan
facility: Hirosaki National Hospital
state: Aomori
city: Chiba-shi
country: Japan
facility: National Hospital Organization Chiba Medical Center
state: Chiba-ken
city: Kitakyushu
country: Japan
facility: National Hospital Organization Kokura Medical Center
state: Fukuoka
city: Fukuyama
country: Japan
facility: National Hospital Organization Fukuyama Medical Center
state: Hiroshima
city: Hitachi
country: Japan
facility: Hitachi General Hospital
state: Ibaraki
city: Kawasaki
country: Japan
facility: Kawasaki Saiwai Hospital
state: Kanagawa
city: Koushi
country: Japan
facility: Kumamoto Saishunso National Hospital
state: Kumamoto
city: Sendai-shi
country: Japan
facility: National Hospital Organization Sendai Medical Center
state: Miyagi-ken
city: Suzaka-shi
country: Japan
facility: Nagano Prefectural Suzaka Hospital
state: Nagano-ken
city: Iida
country: Japan
facility: Iida Municipal Hospital
state: Nagano
city: Ohmura
country: Japan
facility: National Hospital Organization Nagasaki Medical Center
state: Nagasaki
city: Kawachinagano
country: Japan
facility: National Hospital Organization Osaka Minami Medical Center
state: Osaka
city: Koshigaya
country: Japan
facility: Koshigaya Municipal Hospital
state: Saitama
city: Kumamoto
country: Japan
facility: National Hospital Organization Kumamoto Medical Center
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Mikamo H, Matsumizu M, Nakazuru Y, Nagashima M. Efficacy and safety of metronidazole injection for the treatment of infectious peritonitis, abdominal abscess and pelvic inflammatory diseases in Japan. J Infect Chemother. 2015 Feb;21(2):96-104. doi: 10.1016/j.jiac.2014.10.005. Epub 2014 Nov 28.