NCT01473836

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 16 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intra-abdominal Infections

Interventions

Type	Name	Description
DRUG	Metronidazole	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.
DRUG	Ceftriaxone sodium	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.

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2011-11-17
• Last updated: 2014-01-24
• Results posted: 2013-12-10

Locations

15 sites across 1 country: Japan