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
Brief Summary

This is an Intermediate-Size Expanded Access, Open-Label Study for Use of Mino-LokTherapy (MLT) in Combination with Systemic Antibiotics in the Treatment of Central LineAssociated Bloodstream Infection. Mino-Lok may be made available for patients whootherwise 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

Available
Intermediate-size Population
Catheter-Related Infections

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
Other Name: Standard of care plus MLT. MLT contains minocycline with EDTA and ethanol.

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.

Eligibility Gender
All
Eligibility Age
Minimum: 12 Years ~ Maximum: N/A
Countries
Puerto Rico
United States
Locations

Phoenix VA Health Care System
Phoenix, Arizona, United States

Yale University School of Medicine
New Haven, Connecticut, United States

Georgetown University Hospital
Washington, District of Columbia, United States

University of Florida - Shands Hospital - Dialysis Center
Gainesville, Florida, United States

Edward Hines Jr. VA Hospital
Hines, Illinois, United States

AMG Oncology
Park Ridge, Illinois, United States

Lutheran Hospital
Park Ridge, Illinois, United States

Indiana Blood and Marrow Institute
Indianapolis, Indiana, United States

Ascension Via Christi Hospital
Wichita, Kansas, United States

University of Kentucky Medical Center
Lexington, Kentucky, United States

Anne Arundel Medical Center
Annapolis, Maryland, United States

Massachusetts General Hospital
Boston, Massachusetts, United States

St. Vincent Hospital
Worcester, Massachusetts, United States

Harper University Hospital
Detroit, Michigan, United States

Henry Ford Health Systems
Detroit, Michigan, United States

William Beaumont Hospital
Troy, Michigan, United States

VA Sierra Nevada Health Care Systems
Reno, Nevada, United States

Saint Michael's Medical Center
Newark, New Jersey, United States

University of New Mexico
Albuquerque, New Mexico, United States

Carolinas Medical Center
Charlotte, North Carolina, United States

East Carolina University
Greenville, North Carolina, United States

University of Cincinnati
Cincinnati, Ohio, United States

University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States

Cleveland Clinic
Cleveland, Ohio, United States

University of Texas MD Anderson Cancer Center
Houston, Texas, United States

Salem VA Medical Center
Salem, Virginia, United States

Seattle Children's Hospital
Seattle, Washington, United States

Manati Medical Center
Manatí, Puerto Rico

Ponce Research Institute
Ponce, Puerto Rico

VA Caribbean Healthcare System
San Juan, Puerto Rico

Contacts

Alan Lader, Ph.D
908-967-6677
expandedaccess@citiuspharma.com

Leonard-Meron Biosciences, Inc.
NCT Number
MeSH Terms
Infections
Catheter-Related Infections
Minocycline
Ethanol