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.
Ages: 12 years and older
Leonard-Meron Biosciences, Inc.
Start Date: 08/22/2018
End Date: 06/30/2018
Last Updated: 11/21/2018
Study HIC#: 2000022741