Inhaled Amikacin Solution BAY41-6551 as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia
Status:
Completed
Trial end date:
2017-04-07
Target enrollment:
Participant gender:
Summary
To demonstrate that as adjunctive therapy to intravenous (IV) antibiotics, BAY 41-6551 400 mg
(amikacin as free base) administered as an aerosol by the Pulmonary Drug Delivery System
(PDDS) Clinical every 12 hours is safe and more effective than placebo (aerosolized normal
saline) administered as an aerosol by the PDDS Clinical every 12 hours, in intubated and
mechanically-ventilated patients with Gram-negative Pneumonia. The secondary endpoint
objectives are to evaluate the superiority of aerosolized BAY 41-6551 versus aerosolized
placebo in pneumonia-related mortality, the Early Clinical Response at Day 10, the days on
ventilation, and the days in the intensive care unit (ICU).