Ignite Creation Date:
2024-07-17 @ 11:11 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06478641
Status:
AVAILABLE
Last Update Posted:
2024-06-27
First Post:
2024-06-22
Brief Title:
Expanded Use in Persistent B Microti Babesiosis
Sponsor:
60 Degrees Pharmaceuticals LLC
Organization:
60 Degrees Pharmaceuticals LLC
Study Overview
Official Title:
Expanded Access Protocol Use of Tafenoquine for Treatment of Babesiosis in Immunocompromised Patients With Persistent Babesia Microti Despite Prior Treatment
Status:
AVAILABLE
Status Verified Date:
2024-06
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:
The purpose of this expanded access protocol is to offer a potentially effective treatment tafenoquine to patients with persistent babesiosis who have not responded to standard of care treatments and who are immunocompromised and thus at risk for more serious complications Tafenoquine will be self-administered orally as 2 x 100 mg dark pink coated tablets once daily total daily dose 200 mg with food on Days 1 2 3 4 then weekly thereafter starting on day 11 until the patient has two consecutive negative PCR tests for Babesia parasites and symptoms of babesiosis have resolved Other standard of care treatments recommended in the 2020 IDSA Guideline on Diagnosis and Management of Babesiosis should also be included in the treatment regimen
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: