To Compare Safety and Efficacy of Doripenem Versus Imipenem-Cilastatin in Patients With Ventilator-Associated Pneumonia

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Ventilator-Associated Pneumonia

In brief

The purpose of this study is to show that doripenem is as effective as imipenem-cilastatin in the treatment of patients with ventilator-associated pneumonia.

Key facts

Study ID

NCT00589693

Run by

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

People needed

274

Starts

2008-04-01

Expected to finish

2011-06-01

Last updated by the study team

2012-12-28

Who can join

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

You may qualify if…

• Patients must have new or worsening radiographic infiltrates consistent with ventilator-associated pneumonia that was not related to cardiac or other disease processes
• Have at least 1 of the following: fever (core body temperature greater than 39.0°C); hypothermia (core body temperature of less than 35.0°C); leukocytosis (increased WBC count); and leukopenia (decreased WBC count)
• Have developed ventilator-associated pneumonia and have been on mechanical ventilation for more than or equal to 48 hours and on mechanical ventilation at the time that study medication is assigned
• Have been hospitalized or been in a chronic care facility for consecutive 5 days or more within the last 90 days
• Have a baseline Clinical Pulmonary Infection Score (CPIS) more than or equal to 6 and an Acute Physiology and Chronic Health Evaluation (APACHE) II score more than 8 and less than 35

You may not qualify if…

• Have received antibiotics for this episode of ventilator-associated pneumonia for more than 24 hours before study medication administration
• Known presence at baseline of only methicillin-resistant Staphylococcus aureus or Stenotrophomonas infection
• Acute respiratory distress syndrome
• Has any of the following conditions: chest trauma with severe lung bruising or loss of stability of the thoracic cage following a fracture of the sternum, ribs, or both, increased amounts of fluid in the lung cavities requiring drainage or pus in the cavity
• Has active seizure disorder within the last 2 years or brain injury such that imipenem cilastatin would not be administered to the patient in usual practice
• Has lung cancer within the last 2 years, chronic bronchitis with an increase in severity within the last 30 days, chronic enlargement of the bronchi or bronchioles related to inflammatory disease or obstruction, lung abscess(s), anatomical bronchial obstruction, respiratory tuberculosis on treatment, suspected atypical pneumonia, chemical pneumonitis, cystic fibrosis, congestive heart failure, severe burns to greater than 15% of the body, evidence of severe and chronic liver disease

Where it is running

• Study site — Newark, Delaware, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Jacksonville, Florida, United States
• Study site — Moline, Illinois, United States
• Study site — Hazard, Kentucky, United States
• Study site — Biddeford, Maine, United States
• Study site — Baltimore, Maryland, United States
• Study site — Detroit, Michigan, United States
• Study site — Butte, Montana, United States
• Study site — Buffalo, New York, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Nashville, Tennessee, United States
• Study site — Houston, Texas, United States
• Study site — Milwaukee, Wisconsin, United States
• Study site — Buenos Aires, Argentina
• Study site — Córdoba, Argentina
• Study site — Entre Ríos, Argentina
• Study site — Monte Grande, Argentina
• Study site — Rio Negro, Argentina
• Study site — Rosario, Argentina
• Study site — Adelaide, Australia
• Study site — Box Hill, Australia
• Study site — Jonesboro, Arkansas, United States

Full record on ClinicalTrials.gov

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