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

Status:

AVAILABLE

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

Lead Sponsor:

Leonard-Meron Biosciences, Inc.

Conditions:

Catheter-Related Infections

Eligibility:

All Genders

12+ years

Brief Summary

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 Infect...

Detailed Description

Eligibility Criteria

Inclusion

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.

Exclusion

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.

Key Trial Info

Start Date :

Trial Type :

EXPANDED_ACCESS

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT04513821

Last Update

August 14 2020

Active Locations (30)

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Page 1 of 8 (30 locations)

Phoenix VA Health Care System

Phoenix, Arizona, United States, 85012

Yale University School of Medicine

New Haven, Connecticut, United States, 06510

Georgetown University Hospital

Washington D.C., District of Columbia, United States, 20007