Status:
COMPLETED
Doripenem in the Treatment of Complicated Intra-Abdominal Infections
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Peninsula Pharmaceuticals, Inc.
Conditions:
Bacterial Infections and Mycoses
Appendicitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 antibioti...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2006
Estimated Enrollment :
478 Patients enrolled
Trial Details
Trial ID
NCT00210938
Start Date
March 1 2004
End Date
January 1 2006
Last Update
June 10 2011
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.