Mino-Lok Therapy (MLT) for the Treatment of CRBSI/CLABSI

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.

Participation Guidelines

Ages: 12 years and older

Gender: Both


Leonard-Meron Biosciences, Inc.

Start Date: 08/22/2018

End Date: 06/30/2018

Last Updated: 11/21/2018

Study HIC#: 2000022741

Get Involved

For more information about this study, contact:
Lindsey Fraczkiewicz
+1 203-785-3490
lindsey.fraczkiewicz@yale.edu

If you would prefer to contact a member of the Help us Discover team about this trial and other similar trials, please email helpusdiscover@yale.edu or call 1-877-978-8348.

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Investigators

Michael Virata

Principal Investigator

Sub-Investigators