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.