A Phase 3 International, Multi-Center, Randomized, Open-Label, Assessor-Blind Study to Evaluate the Efficacy and Safety of Minocycline/EDTA/ Ethanol (Mino-Lok) Therapy (MLT) vs Site-Specific Antimicrobial Lock in Combination with Systemic Antibiotics in the Treatment of Catheter-Related or Central Line-Associated Bloodstream Infection

Document Type

Conference Proceeding

Publication Date

1-11-2026

Publication Title

Open Forum Infect Dis

Keywords

antibiotic agent, antiinfective agent, edetic acid, minocycline, adverse device effect, alcohol, all cause mortality, antimicrobial activity, antimicrobial therapy, bloodstream infection, catheter complication, catheter related bloodstream infection, catheter removal, catheter-related bacteremia, central venous catheter, conference abstract, controlled study, drug therapy, female, Food and Drug Administration, hemodialysis, human, in vitro study, intention to treat analysis, major clinical study, male, mortality, multicenter study, phase 2 clinical trial, phase 3 clinical trial, randomized controlled trial, superiority trial, therapy

Abstract

Background: Catheter-related or central line-associated bloodstream infection (CRBSI/CLABSI) causes substantial morbidity and mortality. Managing CRBSI/ CLABSI often involves removing the infected central venous catheter (CVC) and inserting a new one at a different vascular site. Currently, no adjunct antimicrobial lock therapy (in combination with systemic antibiotics) has been FDA-approved and is urgently needed. Our study evaluated a novel triple combination antimicrobial therapy (Mino Lok (MLT)) containing minocycline, EDTA, and ethanol. MLT has shown broad-spectrum in-vitro activity and positive results in a Phase 2 trial. Methods: This international, multicenter, superiority trial was conducted at 34 sites. Cancer, hemodialysis (HD), or other patients requiring a long-term CVC (LTCVC), aged ≥ 12 years, with CLABSI/CRBSI, were enrolled and randomized in a 1:1 ratio to receive either MLT or site-specific standard of care (SOC) antimicrobial lock for 2 hours/day for 7 days. The primary endpoint was median time to catheter failure (defined as mortality, catheter removal due to inability to administer lock or infectious-related reasons, worsening signs/symptoms, persistent or recurrent bloodstream infection, or deep-seated infection). Results: From February 2018 to February 2024, 241 subjects were enrolled and randomized with 228 receiving study drug. A significant difference in median time to catheter failure in intent-to-treat (ITT) and modified ITT (MITT) populations (p≤ 0.0006) was observed (Figures 1 and 2). The CVC was successfully retained in 57% of patients inMLTvs 38% inSOC (p=0.0025). Clinical and microbiological failure related to the catheter or CLABSI were significantly higher in SOC (p=0.0058 and p=0.012, respectively) (Table 1). Adverse events (AEs), serious AEs (SAEs) and allcause mortality were comparable for the two groups. There were no drug-related SAEs. Conclusion: This phase 3 pivotal study demonstrated MLT to be highly effective and superior to SOC antimicrobial locks in salvaging LTCVCs associated with CRBSI/ CLABSI in cancer, HD and other patients requiring LTCVC. MLT has broadspectrum activity, was well-tolerated, and was not associated with drug-related SAEs. MLT may satisfy an urgent unmet need in the management of CRBSIs/CLABSI.

Volume

13

First Page

S219

Last Page

S220

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