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Project Title:
A Double-Blind, Placebo-Controlled, Parallel Group Phase 2 Dose-Ranging Study of Nebulized Amikacin Delivered Via the Pulmonary Drug Delivery System (PDDS) in Subjects With Ventilator-Associated Pneumonia Due to Gram-Negative Organisms.
Funding agency:
Pfizer
Project Status:
open to enrollment
Principal Investigator:
Scott R. Gunn, MD
Project summary:
This is a multi-center, randomized, double-blind, placebo-controlled, parallel group trial to select the appropriate dose of amikacin to be delivered via Aerogen’s PDDS in critical
care patients with a confirmed diagnosis of VAP. Approximately 108 total patients in an estimated 30 centers will be randomized in a 1:1:1 ratio to receive either 400mg aerosolized amikacin daily, 800mg amikacin daily as divided doses, or placebo daily, in addition to standard iv antibiotic therapy for VAP.
The objective is to select the dose of aerosolized amikacin for use in conjunction with standard intravenous antibiotic therapy to carry forward into planned Phase 3 pivotal trials of patients with VAP. The dose will be based on achieving a Cmax for amikacin in respiratory secretions that is 25X the reference MIC for hospital-acquired organisms, and anAUC0-24h/MIC 100X with one or more of the doses on Day 1.To assess the safety and tolerability of repeat doses of aerosolized amikacin in ventilated patients over the duration of a course of therapy.
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