Expanded Use in Persistent (B. Microti) Babesiosis (NCT06478641) | Clinical Trial Compass
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Expanded Use in Persistent (B. Microti) Babesiosis
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.