NCT02218359 - Aerosolized Amikacin and Fosfomycin in Mechanically Ventilated Patients With Gram-negative and / or Gram-positive Bacterial Colonization | Biotech Hunter

Timeline

Start Date

October 31, 2014

Primary Completion Date

December 31, 2015

Study Completion Date

January 31, 2016

Conditions

Pneumonia, Bacterial

Interventions

DRUG

Amikacin Fosfomycin Inhalation Solution

300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the AFIS Inline System

DRUG

Aerosolized placebo

Placebo twice daily for Days 1 -5 to be administered by aerosol using the eFlow Inline System.

DRUG

Amikacin Fosfomycin Inhalation Solution

Open-label crossover for all patients Days 6-10