Clinical trial NCT04513821: Expanded Access: Mino-Lok Therapy (MLT) for the Treatment of CRBSI/CLABSI
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
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Catheter-Related Infections
Lead sponsor: Leonard-Meron Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2020-08-14
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT

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 )

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

Eligibility criteria: 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.

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