Expanded Access: Mino-Lok Therapy (MLT) for the Treatment of CRBSI/CLABSI

Available (expanded access)

Conditions studied: Catheter-Related Infections

In brief

This is an Intermediate-Size Expanded Access, Open-Label Study for Use of Mino-Lok Therapy (MLT) in Combination with Systemic Antibiotics in the Treatment of Central Line Associated Bloodstream Infection. Mino-Lok may be made available for patients who otherwise do not qualify for the phase 3 clinical trial (NCT02901717 )

Key facts

Study ID

NCT04513821

Run by

Leonard-Meron Biosciences, Inc.

Last updated by the study team

2020-08-14

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject or a legally authorized representative must provide a signed informed consent form;
• The subject should be male or female at least 12 years of age. This product has not been studied in a younger pediatric population;
• 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.
• Subjects for whom, in the Investigator's opinion, catheter retention is reasonable or required;
• 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.

You may not qualify if…

• Subjects who meet any of the following criteria should not be exposed to MLT:
• Subjects with hypersensitivity or allergy to tetracycline antibiotics or edetate disodium;
• Subjects taking disulfiram at the time of enrollment or who are expected to take disulfiram at any time during treatment with study drug;
• 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;
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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