NCT01799993

Inhaled Amikacin Solution BAY41-6551 as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 725 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Pneumonia, Bacterial

Interventions

Type	Name	Description
DRUG	Amikacin Inhalation Solution (BAY41-6551)	400 mg of aerosolized amikacin every 12 hours for 10 days to be administered using the Pulmonary Drug Delivery System (PDDS Clinical)
DRUG	Aerosolized Placebo	Aerosolized placebo every 12 hours for 10 days to be administered using the Pulmonary Drug Delivery System (PDDS Clinical)

Timeline

• Start date: 2013-04-13
• Primary completion: 2017-04-07
• Completion: 2017-04-07
• First posted: 2013-02-27
• Last updated: 2018-07-23
• Results posted: 2018-06-26

Locations

65 sites across 12 countries: United States, Australia, Brazil, Canada, Colombia, Czechia, Mexico, Philippines, South Korea, Taiwan, Thailand, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study