Mino-Lok Therapy (MLT) for the Treatment of CRBSI/CLABSI
- Registration Number
- NCT02901717
- Lead Sponsor
- Leonard-Meron Biosciences, Inc.
- Brief Summary
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.
- Detailed Description
This is a Phase 3, multi-center, randomized, double-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.
Mino-Lok Therapy is being developed as an adjunctive therapy for the treatment of catheter-related or central line associated bloodstream infection (CRBSI/CLABSI) in combination with appropriate systemic antibiotic(s), to preserve central venous access and to avoid the complications and morbidities associated with catheter removal and reinsertion.
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: MLT + SOC intravenous (IV) antibiotic therapy; or
* Control Arm (subjects randomized to the Control Arm will receive treatment based on the type and virulence of the infecting organism as documented by the Investigator prior to randomization): The antibiotic lock should be comprised of the best available therapy at the sites. Prior to randomization, the Investigator at each site will determine the antibiotic used in the lock, the dose, the dwell time, and the number of days of administration (minimum of 7 days) based on standard institutional practices or recommendations from the Infectious Diseases Society of America (IDSA) guidelines. In the event that the subject is being treated with more than 1 systemic SOC IV antibiotic, the Investigator will specify a single antibiotic that should be used for the antibiotic lock. It is acceptable for the SOC antibiotic lock to differ from the SOC IV antibiotics, as necessary per local SOC.
All infecting organism types are permitted (eg, S. aureus, S. epidermidis, Candida spp., Pseudomonas aeruginosa). Randomization will be stratified by type of CVC, presence of neutropenia, and by virulence of the infecting organism.
The primary endpoint for this study is the time (in days following randomization) to a catheter failure event between randomization and TOC (Week 6) in the Intent-to-Treat (ITT) Population.
A catheter failure event is ANY of the following:
* All-cause mortality at TOC (Week 6). The event time is the day of death;
* Catheter removal for any infection-related reasons (including worsening of symptoms or failure to eradicate the infection). The event time is the day the catheter is removed;
* Inability to administer study drug. The event time is the day the Investigator determines the catheter is no longer functional;
* Worsening of systemic signs and symptoms of infection that result in change in systemic anti infective treatment. Note that changes in treatment based on susceptibility data will be permitted. The event time is the day the treatment is changed;
* Demonstration that the baseline pathogen is not eradicated from the blood culture collected within 72 hours following randomization despite 72 hours of antibiotic therapy to which the infecting organism is susceptible. Best clinical practice and subject safety may dictate changes in treatment prior to 72 hours. The event time is the day of the positive culture;
* Demonstration that the baseline pathogen has recurred based on blood culture results by Week 6 of the study. The event time is the day of the positive blood culture documenting the recurrence. If a subject does not show any signs and symptoms of an infection and there is a negative blood culture prior to Week 6, then a blood culture does not have to be performed at Week 6. Subjects whose catheter was removed for reasons not related to the baseline infection also do not need to have a blood culture at Week 6; or
* Demonstration that the baseline pathogen is part of a newly diagnosed deep-seated infection by Week 6 of the study. The event time is the day of the new diagnosis.
Removal of the CVC prior to TOC because the catheter is no longer needed will not be considered a catheter failure and these subjects will be censored at the time of catheter removal.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 144
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard of Care Antibiotic lock Antibiotic lock + standard of care antibiotics. The standard of care antibiotic will be chosen by the investigator at the time of the infection. Mino-Lok Therapy (MLT) Mino-Lok Standard of care plus MLT. MLT contains minocycline with EDTA and ethanol.
- Primary Outcome Measures
Name Time Method Time to a catheter failure event. 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.
- Secondary Outcome Measures
Name Time Method Proportion of subjects with overall success in the MITT and CE populations. 6 weeks Overall success is defined as no catheter failure events by TOC (week 6).
Microbiological eradication 6 weeks Proportion of subjects with Microbiological Eradication at TOC (Week 6) in the MITT and CE Populations.
All-cause mortality 6 weeks Death within 6 weeks of randomization
Time to catheter failure in the MITT and CE Populations. 6 weeks The time (in days following randomization) to a catheter failure event between randomization and TOC (Week 6).
Clinical Cure 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.Safety and Tolorability 6 Weeks Safety and tolerability profile as assessed by adverse events, serious adverse events (SAEs), vital signs, clinical laboratory evaluations, and physical examinations.
Trial Locations
- Locations (22)
University of Florida Shands Hospital
🇺🇸Gainesville, Florida, United States
Edward Hines Jr. VA Hospital
🇺🇸Hines, Illinois, United States
Ascension Via Christi Hospital
🇺🇸Wichita, Kansas, United States
University of Kentucky Medical Center
🇺🇸Lexington, Kentucky, United States
Anne Arundel Medical Center
🇺🇸Annapolis, Maryland, United States
Henry Ford Health Systems
🇺🇸Detroit, Michigan, United States
William Beaumont Hospital
🇺🇸Troy, Michigan, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Salem VA Medical Center
🇺🇸Salem, Virginia, United States
Manati Medical Center
🇵🇷Manatí, Puerto Rico
Ponce Research Institute
🇵🇷Ponce, Puerto Rico
VA Caribbean Healthcare System
🇵🇷San Juan, Puerto Rico
AMG Oncology
🇺🇸Park Ridge, Illinois, United States
Indiana Blood and Marrow Institute
🇺🇸Indianapolis, Indiana, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Saint Michael's Medical Center
🇺🇸Newark, New Jersey, United States
East Carolina University
🇺🇸Greenville, North Carolina, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Georgetown University Hospital
🇺🇸Washington, District of Columbia, United States
VA Sierra Nevada Health Care Systems
🇺🇸Reno, Nevada, United States