Last updated on August 2019

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


Brief description of study

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.

Detailed Study Description

This is a Phase 3, multi-center, randomized, double-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.

Mino-Lok Therapy is being developed as an adjunctive therapy for the treatment of catheter-related or central line associated bloodstream infection (CRBSI/CLABSI) in combination with appropriate systemic antibiotic(s), to preserve central venous access and to avoid the complications and morbidities associated with catheter removal and reinsertion.

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 (subjects randomized to the Control Arm will receive treatment based on the type and virulence of the infecting organism as documented by the Investigator prior to randomization): The antibiotic lock should be comprised of the best available therapy at the sites. Prior to randomization, the Investigator at each site will determine the antibiotic used in the lock, the dose, the dwell time, and the number of days of administration (minimum of 7 days) based on standard institutional practices or recommendations from the Infectious Diseases Society of America (IDSA) guidelines. In the event that the subject is being treated with more than 1 systemic SOC IV antibiotic, the Investigator will specify a single antibiotic that should be used for the antibiotic lock. It is acceptable for the SOC antibiotic lock to differ from the SOC IV antibiotics, as necessary per local SOC.

All infecting organism types are permitted (eg, S. aureus, S. epidermidis, Candida spp., Pseudomonas aeruginosa). Randomization will be stratified by type of CVC, presence of neutropenia, and by virulence of the infecting organism.

The primary endpoint is the proportion of subjects in the ITT Population who have Overall Success at TOC (Week 8). Success is defined as any subject who demonstrates eradication of the pathogen, stabilization or improvement in signs and symptoms of the infection, catheter salvage, AND survival at termination of the study. Analysis for the primary endpoint will compare the overall success rate between the MLT Arm and the Control Arm.

Note: Patients who have had their catheters removed and replaced due to a CLABSI/CRBSI may be eligible for entry into the observation arm.

Clinical Study Identifier: NCT02901717

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William Beaumont Hospital

Troy, MI United States
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