Inhaled Alone versus Inhaled Plus Intravenous Polymyxin B for the Treatment of Pneumonia Due to Carbapenem-Resistant Gram-Negative Bacteria: A Prospective Randomized Controlled Trial
Abstract
Infections due to carbapenem-resistant Gram-negative bacteria (CR-GNB) are associated with considerable morbidity and mortality. Polymyxin B (PMB) is a first-line agent for CR-GNB-associated pneumonia, but limited data exist on the clinical use of inhaled (IH) PMB. A single-center, prospective randomized controlled trial was conducted in China to compare IH PMB alone with IH plus intravenous (IV) PMB between February 2022 and February 2024. The primary outcome was the clinical cure rate. Twenty-two evaluable patients were assigned to the IH group, and 56 patients were included in the IH+IV group. Baseline characteristics were comparable between the two groups. No significant differences were observed in clinical cure rates, favorable clinical outcomes, microbiological outcomes, all-cause mortality, or pneumonia-related mortality. However, IH PMB alone was associated with a lower incidence of nephrotoxicity (P = 0.030). IH PMB demonstrated significantly higher drug concentrations in the epithelial lining fluid (ELF) compared to systemic administration. Patients with immunosuppressive therapy (OR, 0.066; 95% CI, 0.010-0.433; P = 0.005), malignancies (OR, 0.112; 95% CI, 0.016-0.797; P = 0.029), and higher SOFA scores (OR, 0.693; 95% CI, 0.518-0.929; P = 0.014) were less likely to achieve favorable clinical outcomes. Conversely, higher PMB ELF 1-hour concentrations (OR, 1.085; 95% CI, 1.026-1.148; P = 0.004) were associated with more favorable clinical outcomes. The combination…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 56 participants or records.
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