Status:
COMPLETED
A Phase 3 Study Of Intravenous Metronidazole For Intrabdominal Infection
Lead Sponsor:
Pfizer
Conditions:
Intra-abdominal Infections
Eligibility:
All Genders
16-79 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT01473836
Start Date
November 1 2011
End Date
October 1 2012
Last Update
January 24 2014
Active Locations (15)
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1
Daiyukai First Hospital
Ichinomiya, Aichi-ken, Japan
2
Hirosaki National Hospital
Hirosaki, Aomori, Japan
3
National Hospital Organization Chiba Medical Center
Chiba, Chiba, Japan
4
National Hospital Organization Kokura Medical Center
Kitakyushu, Fukuoka, Japan