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
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Tracking Information | |||||
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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 |
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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.
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Expanded Access Status | Available | ||||
Contacts |
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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 |