Expanded Use in Persistent (B. Microti) Babesiosis

November 18, 2025 updated by: 60 Degrees Pharmaceuticals LLC

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

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.

Study Overview

Status

Available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Individual Patients

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

60 Degrees Pharmaceuticals LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

June 22, 2024

First Submitted That Met QC Criteria

June 22, 2024

First Posted (Actual)

June 27, 2024

Study Record Updates

Last Update Posted (Actual)

November 21, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TQ-BA-2024-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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