Doripenem in the Treatment of Complicated Intra-Abdominal Infections
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The purpose of this study is to compare the clinical response rate of doripenem versus a comparator in the treatment of hospitalized patients with complicated intra-abdominal infections.
Full description
Doripenem is an antibiotic medication not yet approved by the US FDA. This is a phase 3, multicenter, prospective, randomized, double-blind study of doripenem versus comparator antibiotic to assess the effectiveness and safety of doripenem in the treatment of complicated intra-abdominal infections in hospitalized adults. Doripenem or comparator is administered. The primary endpoint is the clinical response measured at late follow-up visit. The patients will receive either doripenem or comparator; treatment duration is 5 to 14 days.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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