Mino-Lok Therapy (MLT) for the Treatment of CRBSI/CLABSI
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|ClinicalTrials.gov Identifier: NCT02901717|
Recruitment Status : Recruiting
First Posted : September 15, 2016
Last Update Posted : October 25, 2019
This is a Phase 3, multi-center, randomized, open-label, assess-blind study to determine the efficacy and safety of MLT, a novel antibiotic lock therapy that combines minocycline with edetate disodium in 25% ethanol solution as an adjuctive therapy for the treatment of catheter-related or central line associated bloodstream infection (CRBSI/CLABSI).
Approximately 144 subjects who have been diagnosed with CRBSI/CLABSI and who meet all necessary criteria for the study will be randomized in a 1:1 ratio to 1 of 2 treatment arms:
- MLT Arm: Mino-Lok therapy; or
- Control Arm: Antibiotic lock (±heparin). The antibiotic lock (ALT) should be comprised of the best available therapy at the sites based on standard institutional practices or recommendations from the Infectious Diseases Society of America (IDSA) guidelines.
|Condition or disease||Intervention/treatment||Phase|
|Catheter-related Infections||Drug: Mino-Lok Drug: Antibiotic lock||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||144 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||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|
|Actual Study Start Date :||February 13, 2018|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||October 2020|
Active Comparator: Standard of Care
Antibiotic lock + standard of care antibiotics. The standard of care antibiotic will be chosen by the investigator at the time of the infection.
Drug: Antibiotic lock
Standard of Care antibiotics appropriate for the infecting organism with an antibiotic lock solution using the same standard of care antibiotic delivered systemically. The antibiotic lock arm may include subjects with S. aureus, including methicillin-resistant S. aureus, vancomycin intermediate S. aureus, or vancomycin-resistant S. aureus; vancomycin resistant enterococci; Candida, Pseudomonas; other Gram negative organisms; or other organisms deemed to be of high virulence per the Investigator. The standard of care antibiotic will be determined by the investigator at the start of treatment.
Other Name: Standard of Care antibiotics with antibiotic lock
Experimental: Mino-Lok Therapy (MLT)
Standard of care plus MLT. MLT contains minocycline with EDTA and ethanol.
Standard of Care antibiotics appropriate for the infecting organism plus Mino-Lok therapy to disinfect and save the catheter.
Other Name: Standard of care antibiotics + Mino-Lok
- Time to a catheter failure event. [ Time Frame: 6 weeks ]The time (in days following randomization) to a catheter failure event between randomization and TOC (Week 6) in the Intent-to-Treat (ITT) Population.
- Proportion of subjects with overall success in the MITT and CE populations. [ Time Frame: 6 weeks ]Overall success is defined as no catheter failure events by TOC (week 6).
- Time to catheter failure in the MITT and CE Populations. [ Time Frame: 6 weeks ]The time (in days following randomization) to a catheter failure event between randomization and TOC (Week 6).
- Microbiological eradication [ Time Frame: 6 weeks ]Proportion of subjects with Microbiological Eradication at TOC (Week 6) in the MITT and CE Populations.
- Clinical Cure [ Time Frame: 6 Weeks ]
Proportion of subjects with Clinical Cure at TOC (Week 6) in the MITT and CE Populations.
Clinical Cure is defined as the absence of baseline CRBSI/CLABSI signs/symptoms or, in the Investigator's opinion, improvement of signs/symptoms such that no additional therapy is necessary.
- All-cause mortality [ Time Frame: 6 weeks ]Death within 6 weeks of randomization
- Safety and Tolorability [ Time Frame: 6 Weeks ]Safety and tolerability profile as assessed by adverse events, serious adverse events (SAEs), vital signs, clinical laboratory evaluations, and physical examinations.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02901717
|Contact: Alan Lader, Ph.D.||email@example.com|