Could an antimalarial drug speed recovery from babesiosis?
NCT ID NCT06207370
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether adding the antimalarial drug tafenoquine to standard care helps hospitalized babesiosis patients recover faster. About 33 adults with confirmed Babesia infection will receive either tafenoquine or a placebo, plus standard antibiotics. Researchers will track how quickly symptoms like fever and fatigue resolve and whether the infection is cleared.
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 provide a faster recovery and more effective treatment for hospitalized babesiosis patients.
- What could go wrong
- This is a small early-phase trial (33 people) testing a drug not yet approved for babesiosis. It may not show benefit or could have side effects.
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.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 33 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2024
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- 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
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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 Babesia. * Exhibiting at least one self-reported clinical symptoms of babesiosis. * Able and willing to give written informed consent. * Expected to be hospitalized at the time of or following informed consent and still hospitalized on the day of randomization and start of investigational products. * Willing to complete the study activities and assessments. * Must agree not to enroll in another study of an investigational agent prior to completion of the study. * Able to take oral medications. * If female of reproductive age, must agree to use an acceptable method of birth control. * Adequate venous access. * Blood hemoglobin ≥ 7 g/dL. Exclusion Criteria: * Have any contraindications to TQ. * Have any contraindication for azithromycin or atovaquone. * Any concomitant significant illness unrelated to babesiosis. * Receipt of any experimental treatment for babesiosis. * Taking any excluded concomitant medication. * Current or planned treatment with quinine while participating in the study. * Positive pregnancy test. * If A/A was initiated more than 48h prior to randomization and parasitemia is not \>1%. * Azithromycin or atovaquone 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.
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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 places running it
1 site. The list below names each one and where it is.
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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.
Contacts and locations
Locations
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Tufts Medical Center
RECRUITINGBoston, Massachusetts, 02111, United States