Conditions: Intra-abdominal Infections
Keywords: Metronidazole intra-abdominal infection pelvic inflammatory disease anaerobe
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 38
Healthy volunteers: no

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:

Arms:
arm 1: Metronidazole will be administered at a dose of 500 mg TID (or QID for refractory or severe infection) in combination with ceftriaxone sodium

Interventions: intervention 1: Metronidazole intervention 2: Ceftriaxone sodium
Intervention descriptions: intervention 1: Metronidazole will be administered at a dose of 500 mg TID (or QID for refractory or severe infection) for 3 to 14 days, in principle. Treatment duration can be prolonged up to 21 days based on subject's condition. intervention 2: Ceftriaxone sodium will be administered at a daily dose of 2 g (strength) when metronidazole is administered TID or at a daily dose of 4 g (strength) when metronidazole is administered QID.

Protocol document: