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

August 13, 2020 updated by: Leonard-Meron Biosciences, Inc.

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

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 )

Study Overview

Status

Available

Conditions

Intervention / Treatment

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 Type

Expanded Access

Expanded Access Type

  • Intermediate-size Population

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Puerto Rico
      • Manatí, Puerto Rico
        • Available
        • Manati Medical Center
      • Ponce, Puerto Rico
        • Available
        • Ponce Research Institute
      • San Juan, Puerto Rico, 00921
        • Available
        • VA Caribbean Healthcare System
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • Available
        • Phoenix VA Health Care System
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Available
        • Yale University School of Medicine
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Available
        • Georgetown University Hospital
    • Florida
      • Gainesville, Florida, United States, 32608
        • Available
        • University of Florida - Shands Hospital - Dialysis Center
    • Illinois
      • Hines, Illinois, United States, 60141
        • Available
        • Edward Hines Jr. VA Hospital
      • Park Ridge, Illinois, United States, 60068
        • Available
        • AMG Oncology
      • Park Ridge, Illinois, United States, 60068
        • Available
        • Lutheran Hospital
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • Available
        • Indiana Blood and Marrow Institute
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Available
        • Ascension Via Christi Hospital
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Available
        • University of Kentucky Medical Center
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Available
        • Anne Arundel Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Available
        • Massachusetts General Hospital
      • Worcester, Massachusetts, United States, 01608
        • Available
        • St. Vincent Hospital
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Available
        • Harper University Hospital
      • Detroit, Michigan, United States, 48202
        • Available
        • Henry Ford Health Systems
      • Troy, Michigan, United States, 48083
        • Available
        • William Beaumont Hospital
    • Nevada
      • Reno, Nevada, United States, 89502
        • Available
        • VA Sierra Nevada Health Care Systems
    • New Jersey
      • Newark, New Jersey, United States, 07102
        • Available
        • Saint Michael's Medical Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Available
        • University of New Mexico
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Available
        • Carolinas Medical Center
      • Greenville, North Carolina, United States, 27858
        • Available
        • East Carolina University
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Available
        • University of Cincinnati
      • Cleveland, Ohio, United States, 44195
        • Available
        • Cleveland Clinic
      • Cleveland, Ohio, United States, 44106
        • Available
        • University Hospitals Cleveland Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • Available
        • University of Texas MD Anderson Cancer Center
    • Virginia
      • Salem, Virginia, United States, 24153
        • Available
        • Salem VA Medical Center
    • Washington
      • Seattle, Washington, United States, 98105
        • Available
        • Seattle Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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.
  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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leonard-Meron Biosciences, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

August 10, 2020

First Submitted That Met QC Criteria

August 13, 2020

First Posted (Actual)

August 14, 2020

Study Record Updates

Last Update Posted (Actual)

August 14, 2020

Last Update Submitted That Met QC Criteria

August 13, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CITI-100 EA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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