A Phase 3 Study Of Intravenous Metronidazole For Intrabdominal Infection
- Conditions
- Intra-abdominal Infections
- Interventions
- Registration Number
- NCT01473836
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
- 16 years of age or older.
- Diagnosed with intra-abdominal infections or pelvic inflammatory diseases.
- Can be obtained a specimen for bacteriological efficacy assessment.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Metronidazole Metronidazole Metronidazole will be administered at a dose of 500 mg TID (or QID for refractory or severe infection) in combination with ceftriaxone sodium Metronidazole Ceftriaxone sodium Metronidazole will be administered at a dose of 500 mg TID (or QID for refractory or severe infection) in combination with ceftriaxone sodium
- Primary Outcome Measures
Name Time Method Clinical Response: Response Rate (Data Review Committee Assessment) Baseline to EOT (up to 14 days), TOC Clinical response was evaluated by the data review committee as effective (cured or improved), ineffective (not meeting "effective" criteria), or indeterminate at the end of treatment (EOT) and the test of cure (TOC: 7 days after EOT) based on clinical symptoms, ultrasound images and necessity of other treatment. TOC was the primary analysis of this outcome measure. Cured = clinical symptoms and abnormal findings at the start of the study were disappeared and considered other antibiotics were not required during the study and after the assessment time point. Improved = clinical symptoms and abnormal findings at the start of the study were improved and considered other antibiotics were not required during the study and after the assessment time point. Response rate was calculated from the following formula; "number of participants evaluated as effective" over "total number of participants that excluding ones evaluated as indeterminate" multiplied by 100.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Who Was Assessed as Appropriate to Continue Treatment (Investigator Assessment) Baseline to Day 4 The appropriateness of treatment continuation was evaluated on Day 4 by the investigator as continuation, discontinuation or indeterminate based on the clinical response. The percentage of participants was calculated from the following formula; "number of participants assessed as continuation" over "total number of participants that excluding ones assessed as indeterminate" multiplied by 100.
Bacteriological Response: Eradication Rate (Data Review Committee Assessment) Baseline to Day 4, EOT (up to 14 days), TOC Bacteriological response was evaluated as eradication (eradication, presumed eradication or colonization), persistence, or indeterminate by the data review committee, at Day 4, at the end of treatment (EOT), and the test of cure (TOC: 7 days after EOT). Eradication Rate was calculated from the following formula, "number of participants with bacteria eradication, presumed eradication or colonization" over "total number of participants that excluding ones evaluated as indeterminate" multiplied by 100.
Clinical Response: Response Rate (Investigator Assessment) Baseline to EOT (up to 14 days), TOC Clinical response was evaluated by the investigator as effective (cured or improved), ineffective (not meeting "effective" criteria), or indeterminate at the end of treatment (EOT) and the test of cure (TOC: 7 days after EOT) based on clinical symptoms, ultrasound images and necessity of other treatment. TOC was the primary analysis of this outcome measure. Cured = clinical symptoms and abnormal findings at the start of the study were disappeared and considered other antibiotics were not required during the study and after the assessment time point. Improved = clinical symptoms and abnormal findings at the start of the study were improved and considered other antibiotics were not required during the study and after the assessment time point. Response rate was calculated from the following formula; "number of participants evaluated as effective" over "total number of participants that excluding ones evaluated as indeterminate" multiplied by 100.
Bacteriological Response: Eradication Rate (Investigator Assessment) Baseline to Day 4, EOT (up to 14 days), TOC Bacteriological response was evaluated as eradication (eradication, presumed eradication or colonization), persistence, or indeterminate by the investigator at the end of treatment (EOT), and the test of cure (TOC: 7 days after EOT). Eradication Rate was calculated from the following formula, "number of participants with bacteria eradication, presumed eradication or colonization" over "total number of participants that excluding ones evaluated as indeterminate" multiplied by 100.
Number of Participants Analyzed for Population Pharmacokinetics (PK) of Metronidazole 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. Population pharmacokinetic analysis of Metronidazole is conducted by combining current study data with other Metronidazole studies.
Trial Locations
- Locations (15)
Iida Municipal Hospital
🇯🇵Iida, Nagano, Japan
National Hospital Organization Kokura Medical Center
🇯🇵Kitakyushu, Fukuoka, Japan
Koshigaya Municipal Hospital
🇯🇵Koshigaya, Saitama, Japan
Daiyukai First Hospital
🇯🇵Ichinomiya, Aichi, Japan
National Hospital Organization Chiba Medical Center
🇯🇵Chiba-shi, Chiba-ken, Japan
Kawasaki Saiwai Hospital
🇯🇵Kawasaki, Kanagawa, Japan
Hitachi General Hospital
🇯🇵Hitachi, Ibaraki, Japan
National Hospital Organization Nagasaki Medical Center
🇯🇵Ohmura, Nagasaki, Japan
Hirosaki National Hospital
🇯🇵Hirosaki, Aomori, Japan
Nagano Prefectural Suzaka Hospital
🇯🇵Suzaka-shi, Nagano-ken, Japan
Kumamoto Saishunso National Hospital
🇯🇵Koushi, Kumamoto, Japan
National Hospital Organization Osaka Minami Medical Center
🇯🇵Kawachinagano, Osaka, Japan
National Hospital Organization Kumamoto Medical Center
🇯🇵Kumamoto, Japan
National Hospital Organization Fukuyama Medical Center
🇯🇵Fukuyama, Hiroshima, Japan
National Hospital Organization Sendai Medical Center
🇯🇵Sendai-shi, Miyagi-ken, Japan