drugset / Trial / NCT00050401

Ventilator-Associated Pneumonia/Hospital-Acquired Pneumonia Requiring Mechanical Ventilatory Support

NCT00050401

Phase 3 Completed 500 enrolled Pfizer
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of the study is to find out if high dose antibiotic (meropenem, MERREM® I.V.), along with another drug called an aminoglycoside (a different type of antibiotic) is effective in decreasing or reducing the rate of antibiotic resistant Pseudomonas aeruginosa, Acinetobacter (germs that can cause pneumonia), and the rate of resistance in other difficult to treat germs which may cause hospital-acquired pneumonia requiring mechanical ventilatory support. The study hopes to show that by increasing the amount of meropenem administered and increasing the duration of infusion (release of the drug into the bloodstream), levels of the drug will stay at target levels in the bloodstream and decrease the ability of difficult to treat germs to resist, or not be killed by, the treatment using this antibiotic (meropenem) or other antibiotics.

Timeline

Start
2002-07
Primary completion
2004-09
Completion
2004-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Meropenem Small molecule 500 mg Intravenous
Subject Meropenem Small molecule 1 g Intravenous
Subject Meropenem Small molecule 2 g Intravenous
Background Tobramycin Small molecule 5 mg/kg Intravenous
Background Vancomycin Other / unclassified 1 g Intravenous

Indications