Doripenem in the Treatment of Hospital-Acquired Pneumonia

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (Industry)

Overall Status

Completed

CT.gov ID

NCT00211003

Collaborator

Peninsula Pharmaceuticals, Inc. (Industry)

240

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the safety and effectiveness of doripenem in patients with hospital-acquired pneumonia (HAP).

Condition or Disease	Intervention/Treatment	Phase
Pneumonia	Drug: doripenem	Phase 3

Detailed Description

Doripenem is an antibiotic medication not yet approved by the US FDA. This is a phase 3, multicenter, prospective, open-label (though with blinded outcome assessments), randomized study of doripenem versus a comparator antibiotic in patients with hospital-acquired pneumonia. The study consists of screening phase, open-label treatment phase, and follow-up. Both patients on ventilator and not on ventilator are enrolled. The primary endpoint is the clinical response rate at early follow-up visit. The patients may receive either doripenem or comparator; total duration of the treatment is 7 to 14 days.

Study Design

Study Type:

Interventional

Actual Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Multicenter, Randomized, Open-Label, Phase 3 Study to Compare the Safety and Effectiveness of Doripenem Versus a Comparator Antibiotic in Hospital-Acquired Pneumonia

Study Start Date :

May 1, 2004

Actual Study Completion Date :

Oct 1, 2006

Outcome Measures

Primary Outcome Measures

Clinical response rate at the early follow-up visit. []

Secondary Outcome Measures

The clinical response rate 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 test results) monitored throughout the study. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients hospitalized for >= 48 hours or those with prior hospital admission of at least 48 hours who were discharged within the last 48 hours.

Exclusion Criteria:

Hospital-acquired pneumonia known at the time of enrollment to be caused by pathogen(s) resistant to certain antibiotics
Any rapidly progressing disease or immediately life-threatening illness

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Peninsula Pharmaceuticals, Inc.

Investigators

Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.