drugset / Trial / NCT01969799

Aerosolized Amikacin and Fosfomycin in Mechanically Ventilated Patients With Gram-negative Pneumonia

NCT01969799

Phase 2 Completed 143 enrolled Cardeas Pharma
RandomizedParallel-groupQuadruple-blindTreatment

Summary

To demonstrate the safety and efficacy of adjunctive therapy with the Amikacin fosfomycin inhalation system (AFIS) versus aerosolized placebo to treat Gram-negative pneumonia in mechanically ventilated patients receiving IV antibiotics.

Timeline

Start
2013-12
Primary completion
2016-03
Completion
2016-04

Drugs

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

Indications