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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00210938

Enrollment

478

Registered

2005-09-21

Start date

2004-03-31

Completion date

2006-01-31

Last updated

2011-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Appendicitis, Bacterial Infections and Mycoses, Cholecystitis, Pancreatitis, Peritonitis

Keywords

Complicated Intra-Abdominal Infections, Appendicitis, Cholecystitis, Peritonitis

Brief summary

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.

Detailed 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 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.

Interventions

DRUGDoripenem

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy 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.

Design outcomes

Primary

Measure	Time frame
Clinical response rate measured at late follow-up visit.	—

Secondary

Measure	Time frame
Clinical response rate measured at early follow-up visit. Microbiological response rate at both early and late follow-up visits. Safety assessment (adverse events, changes in vital signs, laboratory tests results) conducted throughout the study.	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026