A Phase 3 Study Of Intravenous Metronidazole For Intrabdominal Infection

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

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.

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.