Prospective Multicenter Doubleblind Randomized Study of NXL104/Ceftazidime + Metronidazole vs. Meropenem in Treatment of Complicated Intra-abdominal Infections

Pfizer

Status and phase: Completed; Phase 2

Conditions: Complicated Intra-abdominal Infections

Treatments: Drug: ceftazidime/NXL104 + metronidazole; Drug: meropenem

Study type: Interventional

Funder types: Industry

Identifiers

NCT00752219

NXL-104/2002

C3591014 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to determine whether NXL104 plus ceftazidime is effective in the treatment of complicated intra-abdominal infections as compared to a comparator group.

Enrollment: 204 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• complicated intra-abdominal infections

Exclusion criteria

• infections limited to hollow viscus
• ischemic bowel disease without perforation
• acute suppurative cholangitis
• acute necrotizing pancreatitis
• pts to undergo stated abdominal repair, open abdomen technique or marsupialization
• Apache II >25

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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204 participants in 2 patient groups

NXL104/CAZ/MTZ

Experimental group

Description:

NXL104/ceftazidime + metronidazole

Treatment:

Drug: ceftazidime/NXL104 + metronidazole

Meropenem

Active Comparator group

Treatment:

Drug: meropenem