Overview

An Effectiveness, Safety, and Microbiology Study of Doripenem in Patients With Nosocomial (Hospital-acquired) Pneumonia

Status:
Completed
Trial end date:
2008-11-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the effectiveness and safety of doripenem monohydrate in the treatment of patients with nosocomial (hospital-acquired) pneumonia.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
PriCara, Unit of Ortho-McNeil, Inc.
Treatments:
Doripenem
Criteria
Inclusion Criteria:

- Patients suffering from Nosocomial Pneumonia or Ventilator-Associated Pneumonia

- All patients must be hospitalized throughout the treatment period

- Patients must have microbiological samples (respiratory secretions) suitable for
culture and microscopy

Exclusion Criteria:

- Known or suspected severe kidney impairment

- Known or suspected liver dysfunction

- Treatment with any investigational drug or device within 30 days before enrollment

- Patients with one or more of the following: cystic fibrosis, lung abscess, active
tuberculosis

- Women who are pregnant or lactating