Doripenem in the Treatment of Complicated Intra-Abdominal Infections

NCT00229060 | Completed Phase 3

• 1 other identifier: CR005389
• Study Type: interventional
• Target: 483
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

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

Keywords

Complicated Intra-Abdominal Infections; Appendicitis; Cholecystitis; Peritonitis

Outcome Measures

Primary Outcomes (1)

• The clinical response measured at late follow-up visit.

Secondary Outcomes (1)

• The clinical response at early follow-up visit. Microbiological response at both early and late follow-up visits. Safety assessment (adverse events, changes in vital signs, laboratory test results) conducted throughout the study.

Interventions

doripenem DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead
• Peninsula Pharmaceuticals, Inc.: collaborator

Related Publications (2)

• Kaniga K, Flamm R, Tong SY, Lee M, Friedland I, Redman R. Worldwide experience with the use of doripenem against extended-spectrum-beta-lactamase-producing and ciprofloxacin-resistant Enterobacteriaceae: analysis of six phase 3 clinical studies. Antimicrob Agents Chemother. 2010 May;54(5):2119-24. doi: 10.1128/AAC.01450-09. Epub 2010 Mar 8.

  PMID: 20211892 DERIVED

• Zhanel GG, Ketter N, Rubinstein E, Friedland I, Redman R. Overview of seizure-inducing potential of doripenem. Drug Saf. 2009;32(9):709-16. doi: 10.2165/00002018-200932090-00001.

  PMID: 19670912 DERIVED

Related 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 (JNJ-38174942; DORI-08)

MeSH Terms

Conditions

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

Interventions

Doripenem

Condition Hierarchy (Ancestors)

Infections; Intraabdominal Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases; Gallbladder Diseases; Biliary Tract Diseases; Pancreatic Diseases; Peritoneal Diseases

Intervention Hierarchy (Ancestors)

Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 27, 2005
• First Posted: September 29, 2005
• Study Start: March 1, 2004
• Study Completion: March 1, 2006
• Last Updated: June 10, 2011

Record last verified: 2010-04