Ignite Creation Date:
2024-05-06 @ 3:04 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04513821
Status:
AVAILABLE
Last Update Posted:
2020-08-14
First Post:
2020-08-10
Brief Title:
Expanded Access Mino-Lok Therapy MLT for the Treatment of CRBSICLABSI
Sponsor:
Leonard-Meron Biosciences Inc
Organization:
Leonard-Meron Biosciences Inc
Study Overview
Official Title:
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
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MLK
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 CRBSICLABSI in combination with appropriate systemic antibiotics 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 ClinicalTrialsgov identifier NCT number NCT02901717
Mino-Lok Therapy is being developed as an adjunctive therapy for the treatment of catheter-related or central line associated bloodstream infection CRBSICLABSI in combination with appropriate systemic antibiotics 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 ClinicalTrialsgov identifier NCT number NCT02901717
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None