Phase 3 study of Mino-Lok in patients with Catheter infections
Phase of Trial: Phase III
Latest Information Update: 31 Oct 2017
At a glance
- Drugs Alcohol/disodium edetate/minocycline (Primary)
- Indications Catheter infections
- Focus Registrational; Therapeutic Use
- 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.
- 04 Oct 2016 Status changed from planning to recruiting, as per Media release.