Efficacy of adjuvant colistimethate sodium nebulization in ventilator associated pneumonia in pediatric intensive care unit - A randomized controlled study

Abstract

Background and Objective: The treatment of ventilator-associated pneumonia (VAP) caused by multidrug resistant organisms is challenging even with appropriate intravenous antibiotics. The study was conducted to evaluate the efficacy and safety of nebulised Colistimethate sodium (CS) in the treatment of Gram negative VAP. Methods: For this prospective, interventional, open label, intention-to-treat, randomized trial, 40 consecutive patients were enrolled on the suspicion of VAP. After exclusion, 13 patients in CS nebulisation group and 15 patients in normal saline (NS) nebulisation group were randomized and completed the study. All patients were on systemic antibiotics. The clinical cure was the primary outcome and secondary outcomes included were microbiological cure, durations of mechanical ventilation and stay in PICU and adverse events related with nebulization therapy. Results: Two study groups had comparable clinical characteristics. Clinical and microbiological cures occurred in all patients of CS nebulisation group (100%) but in 11 out of 15 (73.3%) patients in NS nebulisation group (p-0.06). The total duration of mechanical ventilation and PICU stay were not significantly different in two groups. No statistically significant differences were observed with regard to adverse events. Conclusion: Aerosolized CS seems to be safe with no major adverse effects and with no clinical and microbiological benefits. There is need for adequately powered, multicentre study.