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
1 other identifier
interventional
478
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2004
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2006
CompletedJune 10, 2011
April 1, 2010
September 13, 2005
June 8, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical response rate measured at late follow-up visit.
Secondary Outcomes (1)
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.
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
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: 20211892DERIVEDZhanel 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: 19670912DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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 13, 2005
First Posted
September 21, 2005
Study Start
March 1, 2004
Study Completion
January 1, 2006
Last Updated
June 10, 2011
Record last verified: 2010-04