The Efficacy of Inhaled Phage Cocktail to Prevent Ventilator-Associated Pneumonia in Children: A Double-Blind Clinical Trial

<b>Background/Objectives</b>: Phage therapy is gaining attention as a potential alternative to antibiotics. This study investigates the potential use of a phage cocktail as a preventive measure against ventilator-associated pneumonia (VAP) in children. <b>Methods</b>: Sixty patients were selected from the pediatric intensive care units for this double-blind clinical trial. The inclusion criteria involved patients requiring invasive mechanical ventilation for more than two days. This, however, excluded newborns and children with bacterial pneumonia. The intervention group received the standard country protocol drugs in addition to 5 mL of phage cocktail suspension administered every 24 h through an in-line mesh nebulizer for 7 days. The two groups were compared in terms of the incidence of VAP, survival rate, and duration of hospitalization. <b>Results</b>: The intervention with phages had a significant impact on reducing the occurrence of VAP compared to the group receiving a placebo. The data showed that there was a significant difference in the occurrence of VAP between the two groups, with a lower percentage of VAP in the phage cocktail group (<i>p</i> < 0.05). Additionally, the cultures of specific bacterial strains did not yield positive results. Notably, there were no significant differences between the intervention and placebo groups in terms of mortality rates and duration of hospitalization (<i>p</i> > 0.05). <b>Conclusions</b>: Inhalation of a phage cocktail shows a promising effect in preventing VAP in PICU patients at a tertiary hospital in Iran with no observed side effects. However, further, larger clinical trials are necessary to validate its efficacy.