Ignite Creation Date:
2024-05-06 @ 3:20 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04597242
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2022-08-31
First Post:
2020-10-20
Brief Title:
Expanded Access Study of Exebacase in COVID-19 Patients With Persistent MRSA Bacteremia
Sponsor:
ContraFect
Organization:
ContraFect
Study Overview
Official Title:
Expanded Access Study of a Single Dose of Exebacase in Addition to Antistaphylococcal Antibiotics for the Treatment of Persistent Methicillin-Resistant Staphylococcus Aureus MRSA Bloodstream Infections Including Right Sided Endocarditis in Patients Who Are Hospitalized With Coronavirus Disease 2019 COVID-19
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label expanded access study of exebacase used in addition to antistaphylococcal antibiotics in adult patients with persistent methicillin-resistant Staphylococcus aureus MRSA bloodstream infections BSI including right-sided endocarditis R-IE who are hospitalized with coronavirus disease 2019 COVID-19 Patients with left-sided endocarditis L-IE are excluded Patients will receive a single dose of exebacase Patients will continue to receive antistaphylococcal antibiotics as prescribed by the treating physician Exebacase Phase 3 study sites Study CF-301-105 may participate in this Expanded Access study Study CF-301-107
Exebacase a direct lytic agent is an entirely new treatment modality against S aureus Exebacase is a recombinantly-produced purified cell wall hydrolase enzyme that results in rapid bacteriolysis potent biofilm eradication synergy with antibiotics low propensity for resistance and the potential to suppress antibiotic resistance when used together with antibiotics Exebacase represents a first-in-field first-in-class treatment with the potential to improve clinical outcome when used in addition to standard-of-care antibiotics to treat S aureus BSI including IE
Exebacase a direct lytic agent is an entirely new treatment modality against S aureus Exebacase is a recombinantly-produced purified cell wall hydrolase enzyme that results in rapid bacteriolysis potent biofilm eradication synergy with antibiotics low propensity for resistance and the potential to suppress antibiotic resistance when used together with antibiotics Exebacase represents a first-in-field first-in-class treatment with the potential to improve clinical outcome when used in addition to standard-of-care antibiotics to treat S aureus BSI including IE
Detailed Description:
None
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