Citius Pharmaceuticals has enrolled the first patient in a Phase III clinical trial evaluating the efficacy and safety of Mino-Loktherapy in combination with systemic antibiotics in the treatment of catheter-related bacteremias (CRBSIs).
The multi-centre, randomised, open-label, assessor-blind study expects to enrol 700 patients in 50 participating institutions across the US.
The trial has randomised its first patient at the Henry Ford Health System in Detroit, Michigan, US.
It will include subjects with documented CRBSI for whom catheter retention is reasonable or required due to lack of alternative venous access.
The trial's primary endpoint is the proportion of subjects who have overall success at the test of cure at week eight.
The study will be considered an overall success if a subject does not demonstrate all-cause mortality at week eight; removal of catheter for any infection-related reason or inability to administer study drug; deterioration of systemic signs and symptoms of infection that result in discontinuation of lock therapy, among others.
Citius Pharmaceuticals president and CEO Myron Holubiak said: “Because of the unique properties of Mino-Lok, we believe we will be able to show that our proprietary therapy, used in a very manageable dosing regimen, namely two hours of lock time for five to seven days, is superior to any other antibiotic locks that require substantially more dwell time and have not been thoroughly studied.
“Mino-Lok would be the first approved antibiotic lock for the treatment of CRBSIs.”
CRBSIs are considered to be some of the most difficult infections to treat, and are a leading cause of healthcare-associated infections (HAIs) with substantial morbidity and mortality.
Patients with CRBSI may be at risk for serious complications such as septic thrombosis, endocarditis, and disseminated infection.