At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Open-Label, Multicenter Study to Assess the Safety and Tolerability of Doripenem Compared With Imipenem in the Treatment of Subjects With Complicated Intra-Abdominal Infections or Ventilator Associated Pneumonia
In Brief
A Phase 2 clinical trial evaluating Imipenem/cilastatin and Doripenem for Pneumonia, Ventilator-Associated and 4 related conditions. Completed, enrolled 146 participants.
Detailed Summary
The purpose of this study is to assess the safety and tolerability of doripenem compared to imipenem in Ventilator-assisted pneumonia and complicated Intra-abdominal Infection. The study population will include hospitalized patients (or patients resident in a chronic health care facility) who have a diagnosis of either Ventilator associated pneumonia or complicated Intra-abdominal Infection.
Study Details
Timeline
Interventions
Vancomycin and/or amikacin may be added as adjunctive therapy as per investigator discretion
Vancomycin and/or amikacin may be added as adjunctive therapy as per investigator discretion
1 gram infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7 to 14 days
1 gram infused over 1 hour at 8 hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7 to 14 days