A Phase 3 Study Of Intravenous Metronidazole For Intrabdominal Infection

Pfizer

Status and phase: Completed; Phase 3

Conditions: Intra-abdominal Infections

Treatments: Drug: Ceftriaxone sodium; Drug: Metronidazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT01473836

A6831005

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Ages: 16 to 79 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

Metronidazole

Experimental group

Description:

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

Treatment:

Drug: Metronidazole

Drug: Ceftriaxone sodium