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Trial record 2 of 2 for:    mino-lok
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Expanded Access: Mino-Lok Therapy (MLT) for the Treatment of CRBSI/CLABSI (MLK)

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ClinicalTrials.gov Identifier: NCT04513821
Expanded Access Status : Available
First Posted : August 14, 2020
Last Update Posted : August 14, 2020
Sponsor:
Information provided by (Responsible Party):
Leonard-Meron Biosciences, Inc.

Tracking Information
First Submitted Date August 10, 2020
First Posted Date August 14, 2020
Last Update Posted Date August 14, 2020
 
Descriptive Information
Brief Title Expanded Access: Mino-Lok Therapy (MLT) for the Treatment of CRBSI/CLABSI
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
Study Type Expanded Access
Expanded Access Type Intermediate-size Population
Intervention 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status Available
Contacts
Contact: Alan Lader, Ph.D 908-967-6677 expandedaccess@citiuspharma.com
Listed Location Countries Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04513821
Current Responsible Party Leonard-Meron Biosciences, Inc.
Original Responsible Party Same as current
Current Study Sponsor Leonard-Meron Biosciences, Inc.
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Leonard-Meron Biosciences, Inc.
Verification Date August 2020