Doripenem in the Treatment of Complicated Intra-Abdominal Infections

A Multicenter, Double-Blind, Randomized, Phase 3 Study of Doripenem Versus Comparator Antibiotic in the Treatment of Complicated Intra-Abdominal Infections

The purpose of this study is to compare the clinical response rates of doripenem versus a comparator antibiotic in treatment of hospitalized patients with complicated intra-abdominal infections.

Doripenem is an antibiotic medication not yet approved by the US FDA. This is a phase 3, multicenter, prospective, randomized, double-blind study of intravenous doripenem versus a comparator antibiotic to assess the effectiveness and safety of doripenem in the treatment of complicated intra-abdominal infections in hospitalized adults. The primary endpoint is the clinical response rate measured at late follow-up visit. The patients will receive either doripenem or comparator; treatment duration is 5 to 14 days.

Inclusion Criteria:

• Has a requirement for surgical intervention within 24 hours of study entry
• Requirement of antibacterial therapy in addition to surgical intervention in certain intra-abdominal infections.

Exclusion Criteria:

• Female patients who are pregnant, nursing, or if of child bearing potential not using a medically accepted, effective method of birth control
• Any rapidly-progressing disease or immediately life-threatening illness.