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Efficacy and Safety of Mino-Lok Therapy (MLT) in Combination With Systemic Antibiotics in the Treatment of Catheter-Related or Central Line-Associated Bloodstream Infection

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Trial Profile

Efficacy and Safety of Mino-Lok Therapy (MLT) in Combination With Systemic Antibiotics in the Treatment of Catheter-Related or Central Line-Associated Bloodstream Infection

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 27 Nov 2024

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At a glance

  • Drugs Alcohol/disodium edetate/minocycline (Primary) ; Antibacterials; Heparin
  • Indications Catheter infections
  • Focus Registrational; Therapeutic Use
  • Sponsors Citius Pharmaceuticals Inc; Leonard Meron Biosciences

    • Most Recent Events

    • 25 Nov 2024 According to a Citius Pharmaceuticals media release, company held a constructive in-person Type C meeting with the U.S. Food and Drug Administration (FDA). The meeting followed successful completion of this trial. The primary discussion centered on responses to the FDA's questions related to Mino-Loks clinical trial data and a pathway to a future submission.
    • 05 Sep 2024 According to a Citius Pharmaceuticals media release, the company will present and host one-on-one investor meetings to present data from this study at the H.C. Wainwright & Co. 26th Annual Global Investment Conference taking place September 9-11, 2024, in New York City.
    • 10 Jul 2024 According to a Citius Pharmaceuticals media release, the company is planning to prepare a submission to the U.S. Food and Drug Administration (FDA) and schedule a Type B meeting.

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