Niederman MS, Alder J, Bassetti M, et al. - In view of often the unsuccessful treatment of ventilated pneumonia despite treatment in accordance to established guidelines, researchers evaluated the value of the combination drug-device Amikacin Inhale as an adjunctive therapy to intravenous standard-of-care antibiotics for pneumonia caused by Gram-negative pathogens in intubated and mechanically ventilated patients. In INHALE, a prospective, double-blind, randomized, placebo-controlled, phase 3 study, two trials (INHALE 1 and INHALE 2) were involved that were done in 153 hospital intensive-care units in 25 countries. Patients were eligible if they were aged 18 years or older; had pneumonia that had been diagnosed by chest radiography and that was reported as being induced by or displaying two risk factors for a Gram-negative, multidrug-resistant pathogen; were intubated and mechanically ventilated; had impaired oxygenation within 48 h before screening; and had a modified Clinical Pulmonary Infection Score of at least 6. They screened 807 patients for eligibility from April 13, 2013, to April 7, 2017, and randomly assigned 725 cases to Amikacin Inhale (362 patients) or aerosolized placebo (363 patients). Outcomes yielded no evidence supporting the utility of inhaled amikacin adjunctive to standard-of-care intravenous therapy in mechanically ventilated patients with Gram-negative pneumonia.