PMB-CROS
Trial question
What is the role of polymyxin B therapy in patients with sepsis caused by carbapenem-resistant Gram-negative bacteria?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
26.0% female
74.0% male
N = 311
311 patients (81 female, 230 male).
Inclusion criteria: patients with sepsis caused by carbapenem-resistant Gram-negative bacteria susceptible to polymyxin B.
Key exclusion criteria: receipt of polymyxin B treatment previously; pregnancy/lactation; known polymyxin B allergy; enrollment in other trials.
Interventions
N=152 high-dose polymyxin B (150 mg loading dose, 75 mg every 12 hours).
N=159 low-dose polymyxin B (100 mg loading dose, 50 mg every 12 hours).
Primary outcome
Clinical response at day 14
62.5%
59.7%
62.5 %
46.9 %
31.3 %
15.6 %
0.0 %
High-dose polymyxin
B
Low-dose polymyxin
B
No significant
difference ↔
No significant difference in clinical response at day 14 (62.5% vs. 59.7%; RR 1.046, 95% CI 0.88 to 1.25).
Secondary outcomes
No significant difference in death at day 14 (23.7% vs. 27.8%; RR 0.856, 95% CI 0.58 to 1.25).
No significant difference in death at day 28 (30.9% vs. 37.7%; RR 0.819, 95% CI 0.6 to 1.12).
Significant increase in survival at day 180 (34.7% vs. 23.4%; HR 1.32, 95% CI 1.01 to 1.73).
Safety outcomes
No significant difference in adverse events.
Conclusion
In patients with sepsis caused by carbapenem-resistant Gram-negative bacteria susceptible to polymyxin B, high-dose polymyxin B was not superior to low-dose polymyxin B with respect to clinical response at day 14.
Reference
Shaohua Liu, Ying Wu, Shaoyan Qi et al. Polymyxin B therapy based on therapeutic drug monitoring in carbapenem-resistant organisms sepsis: the PMB-CROS randomized clinical trial. Crit Care. 2023 Jun 13;27(1):232.
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