Experimental drug offers hope for stubborn Tick-Borne infection
NCT ID NCT06478641
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This expanded access program provides tafenoquine, an antimalarial drug, to immunocompromised patients with persistent babesiosis (a tick-borne illness) who haven't gotten better with standard treatments. Participants take the drug daily for 4 days, then weekly until they test negative for the parasite and symptoms resolve. The goal is to offer a potential treatment option for those at higher risk of complications.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Tafenoquine (an antimalarial drug)
- What this could lead to
- If it works, this could offer a treatment option for immunocompromised patients with persistent babesiosis who have not responded to standard care.
- What could go wrong
- This is an expanded access program, not a formal trial, so evidence is limited. The drug may not work for everyone, and side effects are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.