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

Catheter-Related Infections Clinical Trial

— MLK  

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

Clinical Trial Details — Status: Available

Administrative data

• NCT number: NCT04513821
• Other study ID #: CITI-100 EA
• Status: Available

Study information

• Verified date: August 2020
• Source: Leonard-Meron Biosciences, Inc.
• Contact: Alan Lader, Ph.D
• Phone: 908-967-6677
• Email: expandedaccess[@]citiuspharma.com
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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 )

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

Recruitment information / eligibility

• Status: Available
• Enrollment: 0
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Catheter-Related Infections
• Infection

Intervention

Drug:
• Mino-Lok Therapy (MLT)
Standard of Care antibiotics appropriate for the infecting organism plus Mino-Lok therapy to disinfect and save the catheter. Mino-Lok is made available through this expanded access protocol to patients who otherwise do not qualify for the phase 3 clinical trial (NCT02901717) Other Name: Standard of care antibiotics + Mino-Lok

Locations

Country	Name	City	State
Puerto Rico	Manati Medical Center	Manatí
Puerto Rico	Ponce Research Institute	Ponce
Puerto Rico	VA Caribbean Healthcare System	San Juan
United States	University of New Mexico	Albuquerque	New Mexico
United States	Anne Arundel Medical Center	Annapolis	Maryland
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	University of Cincinnati	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Harper University Hospital	Detroit	Michigan
United States	Henry Ford Health Systems	Detroit	Michigan
United States	University of Florida - Shands Hospital - Dialysis Center	Gainesville	Florida
United States	East Carolina University	Greenville	North Carolina
United States	Edward Hines Jr. VA Hospital	Hines	Illinois
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Indiana Blood and Marrow Institute	Indianapolis	Indiana
United States	University of Kentucky Medical Center	Lexington	Kentucky
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Saint Michael's Medical Center	Newark	New Jersey
United States	AMG Oncology	Park Ridge	Illinois
United States	Lutheran Hospital	Park Ridge	Illinois
United States	Phoenix VA Health Care System	Phoenix	Arizona
United States	VA Sierra Nevada Health Care Systems	Reno	Nevada
United States	Salem VA Medical Center	Salem	Virginia
United States	Seattle Children's Hospital	Seattle	Washington
United States	William Beaumont Hospital	Troy	Michigan
United States	Georgetown University Hospital	Washington	District of Columbia
United States	Ascension Via Christi Hospital	Wichita	Kansas
United States	St. Vincent Hospital	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Leonard-Meron Biosciences, Inc.

Countries where clinical trial is conducted

United States,  Puerto Rico,