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METHODS: We assessed the safety and efficacy of the amikacin fosfomycin inhalation system (AFIS) for the treatment of Gram-negative bacterial VAP in a randomized double-blind, placebo-controlled, parallel group, phase 2 study between May 2013 and March 2016. We compared standard of care in each arm plus 300 mg amikacin/120 mg fosfomycin or placebo (saline), delivered by aerosol twice daily for 10 days (or to extubation if <10 days) via the investigational eFlow Inline System (PARI GmbH, Germany). The primary efficacy endpoint was change from baseline in the Clinical Pulmonary Infection Score (CPIS) during the randomized course of AFIS/placebo, using the subset of patients with microbiologically proven baseline infections with Gram-negative bacteria. RESULTS: 143 patients were randomized, 71 to AFIS, 72 to placebo. Comparison of CPIS change from baseline between treatment groups was not different (P=0.70). The secondary hierarchical endpoint of no mortality and clinical cure at Day 14 or earlier was also not significant (P=0.68) nor the hierarchical endpoint of no mortality and ventilator free days (P=0.06). Mortality was 17 (24%) in AFIS, 12 (17%) in placebo P=0.32. The AFIS group had significantly fewer positive tracheal cultures on Days 3 and 7 compared to placebo. 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