Expanded Access: Mino-Lok Therapy (MLT) for the Treatment of CRBSI/CLABSI
NCT ID: NCT04513821
Last Updated: 2020-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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AVAILABLE
EXPANDED_ACCESS
Brief Summary
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Detailed Description
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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.
This is an expanded access program (EAP). This program is designed to provide access to Mino-Lok. A physician must decide whether the potential benefit outweighs the risk of receiving an investigational therapy.
To learn more about this study, please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02901717
Conditions
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Interventions
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Mino-Lok Therapy (MLT)
Standard of Care antibiotics appropriate for the infecting organism plus Mino-Lok therapy to disinfect and save the catheter. Mino-Lok is made available through this expanded access protocol to patients who otherwise do not qualify for the phase 3 clinical trial (NCT02901717) Other Name: Standard of care antibiotics + Mino-Lok
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. The subject should be male or female at least 12 years of age. This product has not been studied in a younger pediatric population;
3. Subject should have a bloodstream infection with no other apparent source other than the CVC that meets one of the following criteria:
* A recognized single pathogen cultured from 1 or more blood cultures; OR
* A common skin contaminant cultured from 2 or more blood cultures drawn on the same or consecutive calendar days from a subject with fever (\>38.0 C), chills, or hypotension (systolic blood pressure \<90 mmHg); Note that these criteria are based on the CDCs definition of CLABSI. Please consult the CDC website for guidance at https://www.cdc.gov/nhsn/pdfs/pscmanual/4psc\_clabscurrent.pdf.
4. Subjects for whom, in the Investigator's opinion, catheter retention is reasonable or required;
5. This product has not been studied in women who are pregnant or lactating. It's effect on sperm development has also not been studied. Please consider this with female patients that are pregnant or who plan to become pregnant, or female patients who are breastfeeding. Likewise, male patients should refrain from sperm donation for 90 days following exposure to MLT. NOTE: Highly effective methods of contraception include hormonal contraceptives, intrauterine device, double-barrier method, partner sterility, or abstinence are strongly recommended.
Exclusion Criteria
1. Subjects with hypersensitivity or allergy to tetracycline antibiotics or edetate disodium;
2. Subjects taking disulfiram at the time of enrollment or who are expected to take disulfiram at any time during treatment with study drug;
3. The benefit of MLT in subjects with prosthetic cardiac valves, vascular grafts, pacers, automatic implantable cardioverter-defibrillator, or other non-removable vascular foreign body should be evaluated prior to exposure. The Investigator should be confident that these are not the source of infection;
4. The benefit of MLT in subjects with a deep-seated intravascular source of infection (eg, endocarditis \[as evidenced by vegetations on an echocardiogram or clinical suspicion\] or septic thrombosis) should be evaluated prior to exposure. The Investigator should be confident that these are not the source of infection.
12 Years
ALL
No
Sponsors
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Leonard-Meron Biosciences, Inc.
INDUSTRY
Responsible Party
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Locations
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Phoenix VA Health Care System
Phoenix, Arizona, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Georgetown University Hospital
Washington D.C., District of Columbia, United States
University of Florida - Shands Hospital - Dialysis Center
Gainesville, Florida, United States
Edward Hines Jr. VA Hospital
Hines, Illinois, United States
AMG Oncology
Park Ridge, Illinois, United States
Lutheran Hospital
Park Ridge, Illinois, United States
Indiana Blood and Marrow Institute
Indianapolis, Indiana, 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
Massachusetts General Hospital
Boston, Massachusetts, United States
St. Vincent Hospital
Worcester, Massachusetts, United States
Harper University Hospital
Detroit, Michigan, United States
Henry Ford Health Systems
Detroit, Michigan, United States
William Beaumont Hospital
Troy, Michigan, United States
VA Sierra Nevada Health Care Systems
Reno, Nevada, United States
Saint Michael's Medical Center
Newark, New Jersey, United States
University of New Mexico
Albuquerque, New Mexico, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Salem VA Medical Center
Salem, Virginia, United States
Seattle Children's Hospital
Seattle, Washington, United States
VA Caribbean Healthcare System
San Juan, PR, Puerto Rico
Manati Medical Center
Manatí, , Puerto Rico
Ponce Research Institute
Ponce, , Puerto Rico
Countries
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Central Contacts
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Other Identifiers
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CITI-100 EA
Identifier Type: -
Identifier Source: org_study_id
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