Mino-Lok Therapy (MLT) for the Treatment of CRBSI/CLABSI
Status:
Recruiting
Trial end date:
2022-06-01
Target enrollment:
Participant gender:
Summary
This is a Phase 3, multi-center, randomized, open-label, assess-blind study to determine the
efficacy and safety of MLT, a novel antibiotic lock therapy that combines minocycline with
edetate disodium in 25% ethanol solution as an adjuctive therapy for the treatment of
catheter-related or central line associated bloodstream infection (CRBSI/CLABSI).
Approximately 144 subjects who have been diagnosed with CRBSI/CLABSI and who meet all
necessary criteria for the study will be randomized in a 1:1 ratio to 1 of 2 treatment arms:
- MLT Arm: Mino-Lok therapy; or
- Control Arm: Antibiotic lock (±heparin). The antibiotic lock (ALT) should be comprised
of the best available therapy at the sites based on standard institutional practices or
recommendations from the Infectious Diseases Society of America (IDSA) guidelines.