Clinical Efficacy of Sitafloxacin-Colistin-Meropenem and Colistin-Meropenem in Patients with Carbapenem-Resistant and Multidrug-Resistant Hospital-Acquired Pneumonia (HAP)/Ventilator-Associated Pneumonia (VAP) in One Super-Tertiary Hospital in Bangkok, Thailand: A Randomized Controlled Trial.

Background: Carbapenem-resistant (CRAB) hospital-acquired pneumonia (HAP)/ventilator-associated pneumonia (VAP) is now a therapeutic problem worldwide.

Method: An open-label, randomized, superiority, single-blind trial was conducted in Rajavithi Hospital, a super-tertiary care facility in Bangkok, Thailand. CRAB HAP/VAP patients were randomly assigned to receive either sitafloxacin-colistin-meropenem or colistin-meropenem. Outcomes in the two groups were then assessed with respect to mortality, clinical response, and adverse effects.

Result: Between April 2021 and April 2022, 77 patients were treated with combinations of either sitafloxacin plus colistin plus meropenem ( = 40) or colistin plus meropenem ( = 37). There were no significant differences between the two groups with respect to all-cause mortality rates at 7 days and 14 days (respectively, 7.5% vs. 2.7%; = 0.616, and 10% vs. 10%; = 1). Patients who received sitafloxacin-colistin-meropenem showed improved clinical response compared with patients who received colistin-meropenem in terms of both intention-to-treat (87.5% vs. 62.2%; = 0.016) and per-protocol analysis (87.2% vs. 67.7%; = 0.049). There were no significant differences between the two groups with respect to adverse effects.

Conclusions: Adding sitafloxacin as a third agent to meropenem plus colistin could improve clinical outcomes in CRAB HAP/VAP with little or no impact on adverse effects. In short, sitafloxacin-meropenem-colistin could be another therapeutic option for combatting CRAB HAP/VAP.