drugset / Trial / NCT02218359

Aerosolized Amikacin and Fosfomycin in Mechanically Ventilated Patients With Gram-negative and / or Gram-positive Bacterial Colonization

NCT02218359

Phase 2 Withdrawn Cardeas Pharma
RandomizedCrossoverTriple-blindTreatment

Summary

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.

Timeline

Start
2014-10
Primary completion
2015-12
Completion
2016-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Amikacin Small molecule 300 mg Inhaled
Subject Fosfomycin Small molecule 120 mg Inhaled

Indications