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