NCT06478641

Expanded Use in Persistent (B. Microti) Babesiosis

Expanded Access Protocol: Use of Tafenoquine for Treatment of Babesiosis in Immunocompromised Patients With Persistent Babesia Microti Despite Prior Treatment

• Status: Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: 60 Degrees Pharmaceuticals LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Persistent Babesiosis

Interventions

Type	Name	Description
DRUG	Tafenoquine	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.

Timeline

• First posted: 2024-06-27
• Last updated: 2025-11-21