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Purpose

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

Eligibility

Eligible Ages
Over 12 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
Study Type
Expanded Access

Recruiting Locations

Phoenix VA Health Care System
Phoenix 5308655, Arizona 5551752 85012

Yale University School of Medicine
New Haven 4839366, Connecticut 4831725 06510

Georgetown University Hospital
Washington D.C. 4140963, District of Columbia 4138106 20007

University of Florida - Shands Hospital - Dialysis Center
Gainesville 4156404, Florida 4155751 32608

Edward Hines Jr. VA Hospital
Hines 4896005, Illinois 4896861 60141

AMG Oncology
Park Ridge 4905367, Illinois 4896861 60068

Lutheran Hospital
Park Ridge 4905367, Illinois 4896861 60068

Indiana Blood and Marrow Institute
Indianapolis 4259418, Indiana 4921868 46237

Ascension Via Christi Hospital
Wichita 4281730, Kansas 4273857 67214

University of Kentucky Medical Center
Lexington 4297983, Kentucky 6254925 40536

Anne Arundel Medical Center
Annapolis 4347242, Maryland 4361885 21401

Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114

St. Vincent Hospital
Worcester 4956184, Massachusetts 6254926 01608

Harper University Hospital
Detroit 4990729, Michigan 5001836 48201

Henry Ford Health Systems
Detroit 4990729, Michigan 5001836 48202

William Beaumont Hospital
Troy 5012639, Michigan 5001836 48083

VA Sierra Nevada Health Care Systems
Reno 5511077, Nevada 5509151 89502

Saint Michael's Medical Center
Newark 5101798, New Jersey 5101760 07102

University of New Mexico
Albuquerque 5454711, New Mexico 5481136 87106

Carolinas Medical Center
Charlotte 4460243, North Carolina 4482348 28203

East Carolina University
Greenville 4469160, North Carolina 4482348 27858

University of Cincinnati
Cincinnati 4508722, Ohio 5165418 45219

University Hospitals Cleveland Medical Center
Cleveland 5150529, Ohio 5165418 44106

Cleveland Clinic
Cleveland 5150529, Ohio 5165418 44195

University of Texas MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030

Salem VA Medical Center
Salem 4784112, Virginia 6254928 24153

Seattle Children's Hospital
Seattle 5809844, Washington 5815135 98105

VA Caribbean Healthcare System
San Juan 4568127, PR, Puerto Rico 00921

Manati Medical Center
Manatí 4566137, Puerto Rico

Ponce Research Institute
Ponce 4566880, Puerto Rico

More Details

Status
Available
Sponsor
Leonard-Meron Biosciences, Inc.

Study Contact

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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.