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

Completed · Phase 2

Conditions studied: Pneumonia, Bacterial Pneumonia, Ventilator-Associated Pneumonia, Infections, Nosocomial

In brief

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.

Key facts

Study ID

NCT00502801

Run by

PriCara, Unit of Ortho-McNeil, Inc.

People needed

185

Starts

2007-08-01

Expected to finish

2008-11-01

Last updated by the study team

2013-09-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Palm Springs, California, United States
• Study site — San Francisco, California, United States
• Study site — Denver, Colorado, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Jacksonville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Decatur, Georgia, United States
• Study site — Hazard, Kentucky, United States
• Study site — Baltimore, Maryland, United States
• Study site — Springfield, Massachusetts, United States
• Study site — Grand Rapids, Michigan, United States
• Study site — Columbia, Missouri, United States
• Study site — St Louis, Missouri, United States
• Study site — Omaha, Nebraska, United States
• Study site — Buffalo, New York, United States
• Study site — Flushing, New York, United States
• Study site — Jamaica, New York, United States
• Study site — Toledo, Ohio, United States
• Study site — Providence, Rhode Island, United States
• Study site — Johnson City, Tennessee, United States
• Study site — Nashville, Tennessee, United States
• Study site — Norfolk, Virginia, United States
• Study site — Morgantown, West Virginia, United States
• Study site — Buenos Aires, Argentina

Full record on ClinicalTrials.gov

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