Mino-Lok Therapy (MLT) for the Treatment of CRBSI/CLABSI
Diseases of the Blood | Infectious Diseases
What is the purpose of this trial?
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.
Approximately 700 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: MLT + SOC intravenous (IV) antibiotic therapy; or
- Control Arm: Antibiotic lock (±heparin) + SOC IV antibiotics. 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.
- Ages12 years and older
- Trial withLeonard-Meron Biosciences, Inc.
- Start Date08/21/2018
- End Date06/29/2018
- Last Updated11/21/2018
- Study HIC#2000022741