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

Sponsor
Leonard-Meron Biosciences, Inc. (Industry)
Overall Status
Available
CT.gov ID
NCT04513821
Collaborator
(none)
30
Locations

Study Details

Study Description

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 Infection. Mino-Lok may be made available for patients who otherwise do not qualify for the phase 3 clinical trial (NCT02901717 )

Condition or Disease Intervention/Treatment Phase
  • Drug: Mino-Lok Therapy (MLT)

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

Study Design

Study Type:
Expanded Access
Official Title:
CITI-100 EA - 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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    1. 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.

    1. Subjects for whom, in the Investigator's opinion, catheter retention is reasonable or required;

    2. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Phoenix VA Health Care System Phoenix Arizona United States 85012
    2 Yale University School of Medicine New Haven Connecticut United States 06510
    3 Georgetown University Hospital Washington District of Columbia United States 20007
    4 University of Florida - Shands Hospital - Dialysis Center Gainesville Florida United States 32608
    5 Edward Hines Jr. VA Hospital Hines Illinois United States 60141
    6 AMG Oncology Park Ridge Illinois United States 60068
    7 Lutheran Hospital Park Ridge Illinois United States 60068
    8 Indiana Blood and Marrow Institute Indianapolis Indiana United States 46237
    9 Ascension Via Christi Hospital Wichita Kansas United States 67214
    10 University of Kentucky Medical Center Lexington Kentucky United States 40536
    11 Anne Arundel Medical Center Annapolis Maryland United States 21401
    12 Massachusetts General Hospital Boston Massachusetts United States 02114
    13 St. Vincent Hospital Worcester Massachusetts United States 01608
    14 Harper University Hospital Detroit Michigan United States 48201
    15 Henry Ford Health Systems Detroit Michigan United States 48202
    16 William Beaumont Hospital Troy Michigan United States 48083
    17 VA Sierra Nevada Health Care Systems Reno Nevada United States 89502
    18 Saint Michael's Medical Center Newark New Jersey United States 07102
    19 University of New Mexico Albuquerque New Mexico United States 87106
    20 Carolinas Medical Center Charlotte North Carolina United States 28203
    21 East Carolina University Greenville North Carolina United States 27858
    22 University of Cincinnati Cincinnati Ohio United States 45219
    23 University Hospitals Cleveland Medical Center Cleveland Ohio United States 44106
    24 Cleveland Clinic Cleveland Ohio United States 44195
    25 University of Texas MD Anderson Cancer Center Houston Texas United States 77030
    26 Salem VA Medical Center Salem Virginia United States 24153
    27 Seattle Children's Hospital Seattle Washington United States 98105
    28 Manati Medical Center Manatí Puerto Rico
    29 Ponce Research Institute Ponce Puerto Rico
    30 VA Caribbean Healthcare System San Juan Puerto Rico 00921

    Sponsors and Collaborators

    • Leonard-Meron Biosciences, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Leonard-Meron Biosciences, Inc.
    ClinicalTrials.gov Identifier:
    NCT04513821
    Other Study ID Numbers:
    • CITI-100 EA
    First Posted:
    Aug 14, 2020
    Last Update Posted:
    Aug 14, 2020
    Last Verified:
    Aug 1, 2020
    Additional relevant MeSH terms:
    Infections
    Catheter-Related Infections
    Ethanol
    Minocycline

    Study Results

    No Results Posted as of Aug 14, 2020