Status:

COMPLETED

Doripenem in the Treatment of Hospital-Acquired Pneumonia

Lead Sponsor:

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Collaborating Sponsors:

Peninsula Pharmaceuticals, Inc.

Conditions:

Pneumonia

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

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

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 v...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

May 1 2004

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2006

Estimated Enrollment :

240 Patients enrolled

Trial Details

Trial ID

NCT00211003

Start Date

May 1 2004

End Date

October 1 2006

Last Update

June 10 2011

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