Randomized Trial Comparing Minocycline-EDTA-Ethanol Lock to Standard-of-Care Antibiotic Lock for Management of Central Line-Associated Bloodstream Infection.

BACKGROUND

Central line-associated bloodstream infections (CLABSI) cause substantial morbidity and mortality. Management often requires removing the infected central venous catheter (CVC) and inserting a new one. Effective catheter-salvage strategies are needed.

METHODS

An international, multicenter, prospective, randomized superiority trial at 34 centers in the United States, Puerto Rico, and India enrolled patients aged ≥12 years with a long-term central venous catheter (CVC) in place for ≥5 days and CLABSI. Participants were randomized 1:1 to receive systemic antibiotics plus minocycline-EDTA-ethanol lock therapy (MLT) or standard-of-care antibiotic lock therapy (SOC-ALT) for 7 to 14 days. The primary endpoint was median time to catheter failure, defined as clinical failure (death, infection-related catheter removal, worsening symptoms) or microbial failure (persistent/recurrent infection or new deep-seated infection attributable to the index CLABSI).

RESULTS

From 2018-2024, 241 patients were randomized; 228 received lock therapy. Catheter retention was higher with MLT than SOC-ALT (57% vs 38%; P = 0.0025). Median time to catheter failure was longer with MLT in both intention-to-treat (not estimable vs 33 days, HR 0.53, P = 0.0006) and modified intention-to-treat populations (not estimable vs 35 days, HR 0.50, P = 0.0005). Clinical catheter failure (13% vs 28%; P = 0.006) and microbiological failure (5% vs 15%; P = 0.012) were lower with MLT. Adverse events, serious adverse events, and mortality were similar between groups, with no drug-related serious adverse events.

CONCLUSIONS

MLT was superior to SOC-ALT in salvaging long-term CVCs in CLABSI and was well tolerated, addressing an unmet need in CLABSI management.