A Phase 3, Multi-Center, Randomized, Open-Label, Assessor-Blind Study to Evaluate the Efficacy and Safety of Mino-Lok Therapy (MLT) in Combination with Systemic Antibiotics in the Treatment of Catheter-Related Bloodstream Infections
Phase of Trial: Phase III
Latest Information Update: 15 Feb 2018
At a glance
- Drugs Alcohol/disodium edetate/minocycline (Primary)
- Indications Catheter infections
- Focus Registrational; Therapeutic Use
- Sponsors Citius Pharmaceuticals Inc
- 15 Feb 2018 According to a Citius Pharmaceuticals Inc. media release, the first patient has been randomized in this study.
- 31 Oct 2017 According to a Citius Pharmaceuticals Inc. media release, the US FDA has granted Fast-Track designation to the investigational program for Mino-Lok.
- 05 Sep 2017 According to a Citius Pharmaceuticals media release, the study design has been amended to remove the saline and heparin placebo control arm and to use an active control arm that conforms with today's current standard of care. The Company also noted that the dwell times and dosing schedules of the antibiotic lock therapy (ALT) active control arm would be changed because there is an extreme level of variability and heterogeneity in how ALTs are dosed and used today.