NCT04513821

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

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

• Status: Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Leonard-Meron Biosciences, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: —

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

Conditions

• Catheter-Related Infections

Interventions

Type	Name	Description
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

Timeline

• First posted: 2020-08-14
• Last updated: 2020-08-14

Locations

30 sites across 2 countries: United States, Puerto Rico