A Prospective phase IIA Multicenter Double-Blinded Randomized Placebo-Controlled Clinical Trial Evaluating the Efficacy and Safety of Inhaled Tobramycin in Patients with Ventilator-Associated Pneumonia (iToVAP)
A prospective, multicenter, double-blinded, randomized, and placebo-controlled clinical trial was conducted to investigate the efficacy of inhaled Tobramycin as an adjunctive treatment for ventilator-associated pneumonia caused by Gram-negative pathogens. The study involved 26 patients in medical and surgical ICUs, with 14 patients assigned to receive Tobramycin Inhal and 12 patients forming the control group. The results demonstrated a significantly higher rate of microbiological eradication of Gram-negative pathogens in the intervention group compared to the control group (p < 0.001). In fact, the probability of eradication was 100% in the intervention group, indicating promising efficacy. However, despite successful eradication, no notable benefits were observed in terms of reduced systemic anti-infective therapy, shorter ICU stay, or improved patient survival.