Back to resultsDoripenem in the Treatment of Complicated Intra-Abdominal Infections
Primary Purpose
Bacterial Infections and Mycoses, Appendicitis, Cholecystitis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Doripenem
Sponsored by
About this trial
This is an interventional treatment trial for Bacterial Infections and Mycoses focused on measuring Complicated Intra-Abdominal Infections, Appendicitis, Cholecystitis, Peritonitis
Eligibility Criteria
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.
Sites / Locations
Outcomes
Primary Outcome Measures
Clinical response rate measured at late follow-up visit.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00210938
First Posted
September 13, 2005
Last Updated
June 8, 2011
Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators
Peninsula Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00210938
Brief Title
Doripenem in the Treatment of Complicated Intra-Abdominal Infections
Official Title
A Multicenter, Double-Blind, Randomized, Phase 3 Study of Doripenem Versus Comparator Antibiotic in the Treatment of Complicated Intra-Abdominal Infections
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators
Peninsula Pharmaceuticals, Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Infections and Mycoses, Appendicitis, Cholecystitis, Pancreatitis, Peritonitis
Keywords
Complicated Intra-Abdominal Infections, Appendicitis, Cholecystitis, Peritonitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
478 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Doripenem
Primary Outcome Measure Information:
Title
Clinical response rate measured at late follow-up visit.
Secondary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Organizational Affiliation
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
20211892
Citation
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.
Results Reference
derived
PubMed Identifier
19670912
Citation
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.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=637&filename=CR005383_CSR.pdf
Description
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
Learn more about this trial
Doripenem in the Treatment of Complicated Intra-Abdominal Infections
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