A Randomized Double-Blind, Placebo-Controlled, Crossover to Open Label, Phase 2 Study of Aerosolized Amikacin and Fosfomycin Delivered Via the Investigational eFlow® AFIS Inline System in Mechanically Ventilated Patients With Gram-negative and/or Gram-positive Bacterial Colonization

NCT02218359 Phase 2 WITHDRAWN

To demonstrate the safety and efficacy of adjunctive therapy with the Amikacin Fosfomycin Inhalation System (AFIS) versus aerosolized placebo in mechanically ventilated patients with Gram-negative and / or Gram-positive bacterial colonization.

Details

Lead sponsor	Cardeas Pharma
Phase	Phase 2
Status	WITHDRAWN
Start date	2014-10
Completion	2016-01

Conditions

• Pneumonia, Bacterial

Interventions

• Amikacin Fosfomycin Inhalation Solution
• Aerosolized placebo
• Amikacin Fosfomycin Inhalation Solution

Primary outcomes

• Change from baseline in tracheal aspirate Gram-negative and Gram-positive bacterial density — 5 day randomized course of study drug
  Change from baseline in tracheal aspirate Gram-negative and Gram-positive bacterial density at the end of the 5-day randomized course of study drug