Polymyxin B therapy based on therapeutic drug monitoring in carbapenem-resistant organisms sepsis: the PMB-CROS randomized clinical trial
Authors' conclusion
A fixed polymyxin B loading dose of 150 mg and a maintenance dose of 75 mg every 12 h was safe for patients with sepsis caused by CR-GNB and improves long-term survival.
Study context
- Population
- Patients with sepsis caused by carbapenem-resistant Gram-negative bacteria susceptible to polymyxin B, 26 hospitals in Henan province, China
- Participants
- 311 patients · 26 hospitals
- Comparison
- High-dose vs low-dose polymyxin B under therapeutic drug monitoring (TDM) guidance
- High-dose (HD)n = 152
- Low-dose (LD)n = 159reference
- Primary endpoint
- Clinical response
- Follow-up
- 14 days
Methodological detailsmulticentre, TDM-guided dosing
- Multicentre
- TDM-guided dosing
Primary result
As reported in the abstract
14-day clinical response
P = 0.527
Secondary outcomes
Target ssAUC0-24 attainment
P = 0.005
Target ssAUC0-24 attainment, septic shock (subgroup)
| Outcome | P value |
|---|---|
| 180-day survival (Kaplan-Meier) · survival advantage in HD | P = 0.037 |
- Target ssAUC0-24 attainment, septic shock (subgroup) — HD septic shock vs all HD subjects (71.4% vs. 63.8%)
- p = 0.037
- Target ssAUC0-24 attainment, septic shock (subgroup) — LD septic shock vs all LD subjects (58.3% vs. 38.9%)
- p = 0.0005
Target AUC compliance and clinical outcomes
- Target AUC compliance not correlated with clinical outcomes
Safety
Acute kidney injury (AKI) and target AUC compliance
- Target AUC compliance correlated with AKI
- P = 0.019
Adverse events
- Did not differ between HD and LD
Original publication
Polymyxin B therapy based on therapeutic drug monitoring in carbapenem-resistant organisms sepsis: the PMB-CROS randomized clinical trial. Crit Care. Published 13 June 2023. doi:10.
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