Doripenem in the Treatment of Complicated Intra-Abdominal Infections

This study has been completed.
Sponsor:
Collaborator:
Peninsula Pharmaceuticals, Inc.
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00210938
First received: September 13, 2005
Last updated: June 8, 2011
Last verified: April 2010

September 13, 2005
June 8, 2011
March 2004
Not Provided
Clinical response rate measured at late follow-up visit.
Same as current
Complete list of historical versions of study NCT00210938 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Bacterial Infections and Mycoses
  • Appendicitis
  • Cholecystitis
  • Pancreatitis
  • Peritonitis
Drug: Doripenem
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
478
January 2006
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Argentina
 
NCT00210938
CR005383
Not Provided
Not Provided
Not Provided
Not Provided
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Peninsula Pharmaceuticals, Inc.
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP