A Phase 3 Study Of Intravenous Metronidazole For Intrabdominal Infection
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Intra-abdominal Infections
Intervention: Metronidazole (Drug); Ceftriaxone sodium (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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.
Clinical Details
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 design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Clinical Response: Response Rate (Data Review Committee Assessment)
Secondary outcome: Clinical Response: Response Rate (Investigator Assessment)Percentage of Participants Who Was Assessed as Appropriate to Continue Treatment (Investigator Assessment) Bacteriological Response: Eradication Rate (Data Review Committee Assessment) Bacteriological Response: Eradication Rate (Investigator Assessment) Number of Participants Analyzed for Population Pharmacokinetics (PK) of Metronidazole
Eligibility
Minimum age: 16 Years.
Maximum age: 79 Years.
Gender(s): Both.
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.
Locations and Contacts
National Hospital Organization Kumamoto Medical Center, Kumamoto, Japan
Daiyukai First Hospital, Ichinomiya, Aichi, Japan
Hirosaki National Hospital, Hirosaki, Aomori, Japan
National Hospital Organization Chiba Medical Center, Chiba-shi, Chiba-ken, Japan
National Hospital Organization Kokura Medical Center, Kitakyushu, Fukuoka, Japan
National Hospital Organization Fukuyama Medical Center, Fukuyama, Hiroshima, Japan
Hitachi General Hospital, Hitachi, Ibaraki, Japan
Kawasaki Saiwai Hospital, Kawasaki, Kanagawa, Japan
Kumamoto Saishunso National Hospital, Koushi, Kumamoto, Japan
National Hospital Organization Sendai Medical Center, Sendai-shi, Miyagi-ken, Japan
Iida Municipal Hospital, Iida, Nagano, Japan
Nagano Prefectural Suzaka Hospital, Suzaka-shi, Nagano-ken, Japan
National Hospital Organization Nagasaki Medical Center, Ohmura, Nagasaki, Japan
National Hospital Organization Osaka Minami Medical Center, Kawachinagano, Osaka, Japan
Koshigaya Municipal Hospital, Koshigaya, Saitama, Japan
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: November 2011
Last updated: December 18, 2013
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