Doripenem in the Treatment of Complicated Intra-Abdominal Infections

Appendicitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00210938
• Other study ID #: CR005383
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: June 8, 2011
• Start date: March 2004
• Est. completion date: January 2006

Study information

• Verified date: April 2010
• Source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 478
• Est. completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Appendicitis
• Bacterial Infections
• Bacterial Infections and Mycoses
• Cholecystitis
• Communicable Diseases
• Infection
• Intraabdominal Infections
• Pancreatitis
• Peritonitis

Intervention

Drug:
• Doripenem

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Peninsula Pharmaceuticals, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical response rate measured at late follow-up visit.
Secondary	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.

External Links

•   A Multicenter, Double-Blind, Randomized, Phase 3 Study to Compare the Safety and Efficacy of Intravenous Doripenem with that of Meropenem in Complicated Intra-abdominal Infections