Clinical Trials at Englewood Hospital: Critical Care
EHMC IRB Study #:E-13-491
Dr. Carmine Gianatiempo
Bayer HealthCare Pharmaceuticals
A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of BAY 41-6551 as Adjunctive Therapy in Intubated and Mechanically-Ventilated Patients with Gram-Negative Pneumonia
Patients of age 18 and older who are intubated or mechanically ventilated and have a microbiologically-confirmed pneumonia caused by Gram-negative organisms
To evaluate the efficacy (superiority) and safety of aerosolized BAY 41-6551 (Amikacin Solution for Inhalation and the Pulmonary Drug Delivery System), versus placebo
Eligible patients will be randomized to receive either: (1) a 10 calendar day (20 doses) course of aerosolized BAY 41-6551 400 mg (amikacin) every 12 hours or (2) placebo (normal saline) administered in the same manner and according to the same schedule. The study drug or placebo will be given as adjunctive therapy. All patients will receive standard antibiotics.