Doripenem in the Treatment of Complicated Intra-Abdominal Infections

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00229060
• Date of registration: 27/09/2005
• Prospective Registration: No
• Primary sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Public title: Doripenem in the Treatment of Complicated Intra-Abdominal Infections
• Scientific title: A Multicenter, Double-Blind, Randomized, Phase 3 Study of Doripenem Versus Comparator Antibiotic in the Treatment of Complicated Intra-Abdominal Infections
• Date of first enrolment: March 2004
• Target sample size: 483
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00229060
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Argentina

Contacts

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

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Pancreatitis

Bacterial Infections and Mycoses

Peritonitis

Appendicitis

Cholecystitis

Intervention(s)

Drug: doripenem

Primary Outcome(s)

The clinical response measured at late follow-up visit.

Secondary Outcome(s)

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.

Secondary ID(s)

CR005389

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Peninsula Pharmaceuticals, Inc.