Observational studyFrontiers in cellular and infection microbiology2026
The efficacy and safety of colistimethate sodium in the treatment of carbapenem-resistant Gram-negative bacilli: a real-world observational study.
Observational study in Frontiers in cellular and infection microbiology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Introduction: As carbapenem-resistant Gram-negative bacilli (CR-GNB) has spread worldwide, colistimethate sodium (CMS) has been reintroduced into clinic, yet high-quality evidence remains scarce; therefore, this study-the first prospective, observational investigation in China-was designed to evaluate the clinical efficacy and safety of CMS in treating CR-GNB. Methods: Between November 2021 and November 2023, nine ICUs in Henan Province consecutively enrolled 222 patients aged ≥14 years with culture-confirmed CR-GNB infection who were planned to receive ≥7 days of intravenous CMS. The primary efficacy endpoints were clinical response and 30-day all-cause mortality; the main safety endpoint was CMS-associated acute kidney injury (AKI). Results: The overall clinical response rate was 82.5% (95% CI: 76.6%-87.3%), consisting of 17.1% complete resolution and 65.4% partial clinical improvement. The microbiological response rate was 79.0%, the bacterial clearance rate was 72.8%, and the 30-day all-cause mortality was 19.8%. Subgroup analyses showed that CR-GNB patients with single-site infection, isolated pulmonary infection, or monomicrobial infection achieved significantly better clinical efficacy. Multivariable regression analysis revealed that higher APACHE II scores (OR = 0.91), multi-site infection (OR = 0.26), and polymicrobial infection (OR = 0.35) were independent risk factors for poor clinical response. Meanwhile, multi-site infection (OR = 4.19) and polymicrobial infection (OR = 2.94) served as independent risk factors for 30-day all-cause mortality. In terms of safety, the overall incidence of adverse events (AEs) was 3.6%, and the incidence of acute kidney injury (AKI) was 20.4%, mostly classified as KDIGO stage I. In addition, patients with elevated baseline serum creatinine demonstrated a significantly higher risk of AKI. Discussion: Overall, CMS-based regimens achieved favorable efficacy in ICU patients with CR-GNB infections, with an acceptable overall safety profile.
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