Citius Pharmaceuticals, Inc. announced that it has advanced its clinical trial for Mino-Lok®, an antibiotic lock solution to salvage catheters in patients with catheter-related bloodstream infections.  Of the 92 events required to complete the trial, the Company estimates that 85 events have been achieved to date. The trial has enrolled 190 patients, of which 16 patients are in active treatment or pending study completion data review, which may result in additional events. The multi-center Mino-Lok® Phase 3 trial continues to recruit patients at 35 clinical trial sites in the U.S. and India.

The Mino-Lok® Phase 3 pivotal superiority trial (NCT02901717 [1]) is a multi-center, randomized, open-label, blinded study to determine the efficacy and safety of Mino-Lok® (MLT), a novel antibiotic lock therapy that combines minocycline with edetate disodium. The primary endpoint for this study is the time (in days following randomization) to a catheter failure event between randomization and TOC (Week 6) in the Intent-to-Treat (ITT) Population. Additional secondary outcome measures include overall success, microbiological eradication, and clinical cure, among others.

Patients diagnosed with catheter related blood stream infections (CRBSI/CLABSI) and who meet all necessary criteria for the study are randomized in a 1:1 ratio to receive either Mino-Lok® therapy or standard of care antibiotic lock therapy. Patients in the Mino-Lok® arm receive one MLT dose daily with a dwell time of two to four hours for a total of seven doses. For subjects in the Control arm, the investigator determines 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.