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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional



Official Title: Efficacy and Safety of Mino-Lok Therapy (MLT) in Combination With Systemic Antibiotics in the Treatment of Catheter-Related or Central Line-Associated Bloodstream Infection

Brief Summary:

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.

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)