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
Sponsors and collaborators
Source ClinicalTrials.gov