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NCT00211016 Clinical Trial

Doripenem in the Treatment of Ventilator-Associated Pneumonia

Pneumonia Clinical Trial

Official title:
A Multicenter, Randomized, Open-Label, Phase 3 Study of Doripenem Versus a Comparator Antibiotic in the Treatment of Ventilator-Associated Pneumonia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00211016
Other study ID # CR005386
Secondary ID
Status Completed
Phase Phase 3
First received September 13, 2005
Last updated June 8, 2011
Start date August 2004
Est. completion date October 2006

Study information
Verified date March 2010
Source Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare the clinical response rate of doripenem versus comparator in patients with ventilator-associated pneumonia (VAP).

Description:

Doripenem is an antibiotic medication not yet approved by the US FDA. This is a phase 3, multicenter, prospective, randomized, open-label study of doripenem versus comparator to assess the effectiveness and safety of doripenem in the treatment of VAP in adult patients. The study consists of screening phase, open-label treatment phase, and follow-up. The treatment duration is from 7 to 14 days. The primary endpoint is the clinical response rate of doripenem at the early follow-up visit. The patients will receive either doripenem or comparator for 7 to 14 days.

Recruitment information / eligibility
Status Completed
Enrollment 318
Est. completion date October 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patient has received mechanical ventilation for > 24 hours

- Presence of a new or progressive infiltrate on chest x-ray

Exclusion Criteria:

- Believed at study entry to have ventilator-associated pneumonia caused solely by pathogen(s) resistant to certain antibiotics

- History of moderate or severe hypersensitivity reactions to certain antibiotics

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• doripenem

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Peninsula Pharmaceuticals, Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical response rate at the early follow-up visit.
Secondary Clinical response rate at the late follow-up visit. Microbiological response at both early and late follow-up visits. Safety assessment (adverse events, vital signs, laboratory test results) conducted throughout the study..
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