Conditions: Pneumonia, Bacterial
Keywords: Gram-negative pneumonia Aerosol antibiotics Mechanical ventilation Amikacin Fosfomycin Pneumonia, Bacterial Pneumonia Bacterial Infections Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 143
Healthy volunteers: no

Brief 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.

Detailed description:
The primary purpose of this study is to demonstrate the safety and efficacy of the amikacin fosfomycin inhalation system (AFIS). AFIS consists of amikacin solution and fosfomycin solution, delivered by aerosol to the lungs via the PARI Investigational eFlow Inline System (eFlow Inline System). All patients will receive a standardized course of intravenous (IV) antibiotics for a minimum of 7 days. Patients will be randomized to receive 10 days of treatment with either AFIS or placebo, in addition to the IV therapy. The primary efficacy endpoint is defined as the change from baseline in the Clinical Pulmonary Infection Score (CPIS) during the randomized course of study drug. The study was designed to enroll up to 150 patients with the desire to enroll at least 140 patients with gram negative pneumonia. The study was terminated at 143 when that goal was achieved

Arms:
arm 1: 300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System. arm 2: Aerosolized placebo twice daily for 10 days administered using the eFlow Inline System

Interventions: intervention 1: Amikacin fosfomycin inhalation solution intervention 2: Aerosolized placebo
Intervention descriptions: intervention 1: 300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System intervention 2: Placebo twice daily for 10 days to be administered by aerosol the eFlow Inline System

Protocol document: