Citius reports that there are now 12 active sites in the US currently enrolling patients with 13 additional medical centers in startup mode which will, when activated, bring site recruitment to 50% of the 50 target institutions planned. There are another 13 centers in feasibility stage.
The Mino-Lok trial is a phase 3, multi-center, randomized, open-label, assessor-blind study to evaluate the efficacy and safety of Mino-Lok therapy in combination with systemic antibiotics in the treatment of catheter-related bloodstream infections (CRBSI). Subjects with documented CRBSI for whom catheter retention is reasonable or required due to lack of alternative venous access will be included.
The primary endpoint for this study is the proportion of subjects who have overall success at the test of cure at week 8.
There will be interim analyses at the 50% and 75% point of the trial as measured by the number of patients treated.
Citius is dedicated to the development and commercialization of critical care products, with a focus on anti-infectives, cancer care, and unique prescription products that use innovative, patented or proprietary formulations of previously approved active pharmaceutical ingredients.
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