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

PHASE3UnknownINTERVENTIONAL
Enrollment

144

Participants

Timeline

Start Date

February 13, 2018

Primary Completion Date

December 31, 2022

Study Completion Date

March 31, 2023

Conditions
Catheter-related Infections
Interventions
DRUG

Mino-Lok

Standard of Care antibiotics appropriate for the infecting organism plus Mino-Lok therapy to disinfect and save the catheter.

DRUG

Antibiotic lock

Standard of Care antibiotics appropriate for the infecting organism with an antibiotic lock solution using the same standard of care antibiotic delivered systemically. The antibiotic lock arm may include subjects with S. aureus, including methicillin-resistant S. aureus, vancomycin intermediate S. aureus, or vancomycin-resistant S. aureus; vancomycin resistant enterococci; Candida, Pseudomonas; other Gram negative organisms; or other organisms deemed to be of high virulence per the Investigator. The standard of care antibiotic will be determined by the investigator at the start of treatment.

Trial Locations (22)

20007

RECRUITING

Georgetown University Hospital, Washington D.C.

21401

SUSPENDED

Anne Arundel Medical Center, Annapolis

24153

RECRUITING

Salem VA Medical Center, Salem

27858

RECRUITING

East Carolina University, Greenville

28203

RECRUITING

Carolinas Medical Center, Charlotte

32608

RECRUITING

University of Florida Shands Hospital, Gainesville

40536

SUSPENDED

University of Kentucky Medical Center, Lexington

44106

RECRUITING

University Hospitals Cleveland Medical Center, Cleveland

46237

RECRUITING

Indiana Blood and Marrow Institute, Indianapolis

48083

SUSPENDED

William Beaumont Hospital, Troy

48202

RECRUITING

Henry Ford Health Systems, Detroit

60068

RECRUITING

AMG Oncology, Park Ridge

60141

RECRUITING

Edward Hines Jr. VA Hospital, Hines

67214

RECRUITING

Ascension Via Christi Hospital, Wichita

77030

RECRUITING

University of Texas MD Anderson Cancer Center, Houston

89502

RECRUITING

VA Sierra Nevada Health Care Systems, Reno

98105

SUSPENDED

Seattle Children's Hospital, Seattle

02114

RECRUITING

Massachusetts General Hospital, Boston

07102

RECRUITING

Saint Michael's Medical Center, Newark

00921

RECRUITING

VA Caribbean Healthcare System, San Juan

Unknown

RECRUITING

Manati Medical Center, Manatí

RECRUITING

Ponce Research Institute, Ponce

All Listed Sponsors
lead

Leonard-Meron Biosciences, Inc.

INDUSTRY

NCT02901717 - Mino-Lok Therapy (MLT) for the Treatment of CRBSI/CLABSI | Biotech Hunter | Biotech Hunter