Expanded Access: Mino-Lok Therapy (MLT) for the Treatment of CRBSI/CLABSI
Purpose
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 )
Condition
- Catheter-Related Infections
Eligibility
- Eligible Ages
- Over 12 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Subject or a legally authorized representative must provide a signed informed consent form; 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
Subjects who meet any of the following criteria should not be exposed to MLT: 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.
Study Design
- Phase
- Study Type
- Expanded Access
Recruiting Locations
Phoenix, Arizona 85012
New Haven, Connecticut 06510
Washington D.C., District of Columbia 20007
Gainesville, Florida 32608
Hines, Illinois 60141
Park Ridge, Illinois 60068
Park Ridge, Illinois 60068
Indianapolis, Indiana 46237
Wichita, Kansas 67214
Lexington, Kentucky 40536
Annapolis, Maryland 21401
Boston, Massachusetts 02114
Worcester, Massachusetts 01608
Detroit, Michigan 48201
Detroit, Michigan 48202
Troy, Michigan 48083
Reno, Nevada 89502
Newark, New Jersey 07102
Albuquerque, New Mexico 87106
Charlotte, North Carolina 28203
Greenville, North Carolina 27858
Cincinnati, Ohio 45219
Cleveland, Ohio 44106
Cleveland, Ohio 44195
Houston, Texas 77030
Salem, Virginia 24153
Seattle, Washington 98105
San Juan, PR, Puerto Rico 00921
ManatÃ, Puerto Rico
Ponce, Puerto Rico
More Details
- Status
- Available
- Sponsor
- Leonard-Meron Biosciences, Inc.
Detailed Description
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 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