Expanded Access: Mino-Lok Therapy (MLT) for the Treatment of CRBSI/CLABSI
ConditionCatheter-Related Infections
Trial statusAvailable
Trial phaseNot listed
Trial typeExpanded Access
Biological sexAll
Age12+
SponsorLeonard-Meron Biosciences, Inc.
About this trial
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 )
Eligibility criteria
Qualifiers
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;
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Mino-Lok Therapy (MLT)
Treatment groups
No treatment groups listed
Locations
30Puerto Rico
VA Caribbean Healthcare System00921, San JuanPR, Puerto Rico
Manati Medical Center Manati Puerto Rico
Ponce Research Institute Ponce Puerto Rico
United States
Arizona
Phoenix VA Health Care System85012, Phoenix United States
Sponsors and collaborators
Leonard-Meron Biosciences, Inc.
Lead sponsor
Source ClinicalTrials.gov