Expanded Use in Persistent (B. Microti) Babesiosis

NCT ID: NCT06478641

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: AVAILABLE
• Study Classification: EXPANDED_ACCESS

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.

Conditions

Persistent Babesiosis

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female, aged ≥ 18 years
• Laboratory confirmed infection with B. microti and exhibiting clinical symptoms of babesiosis
• Able and willing to give written informed consent
• Able to take ARAKODA according to Prescribing Information
• If female willing to take birth control for 90 days
• Have risk factors for relapsing disease
• Azithromycin, atovaquone, and/or clindamycin administered in the last 12 months to treat babesiosis, and, in the opinion of the investigator, high likelihood that current infection represents a relapse or continuation of disease
• Willing to initiate or continue a standard of care antimicrobial regimen

Exclusion Criteria

• Have any of the contraindications for ARAKODA
• Current or planned treatment with quinine while participating in the study
• Any concomitant significant illness unrelated to babesiosis
• Taking any excluded concomitant medication
• The patient is unable to tolerate medication by the oral route

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

60 Degrees Pharmaceuticals LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Katrina Riggs

Role: CONTACT

kriggs@fasttrackresearch.com

3017585522

Other Identifiers

TQ-BA-2024-2

Identifier Type: -

Identifier Source: org_study_id