Citius Pharmaceuticals, Inc. ('Citius') (Nasdaq: CTXR), a late-stage biopharmaceutical company, announced on Friday that it has chosen Biorasi, LLC ('Biorasi'), a global clinical research organisation, to support the expansion of the firm's Phase three Mino-Lok trial to additional sites outside of the United States.
If Mino-Lok (MLT) is approved then it would be the first-and-only antibiotic lock solution FDA-approved to salvage infected central venous catheters (CVCs) causing catheter-related blood stream infections (CRBSIs).
The Mino-Lok Phase 3 pivotal superiority trial (NCT02901717), a multi-centre, randomised, open-label, blinded study, is to study the efficacy and safety of MLT, a novel antibiotic lock therapy that combines minocycline with edetate disodium. During the study, subjects will receive one MLT dose daily with a dwell time of two to four hours for a total of seven doses. The investigator for subjects in the Control arm will determine the antibiotic used in the lock, dose, dwell time, and number of days of administration based on institutional standards or Infectious Diseases Society of America (IDSA) guidelines.
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