Actively Recruiting
Oral Tafenoquine Plus Standard of Care Versus Placebo Plus Standard of Care for Babesiosis
Led by 60 Degrees Pharmaceuticals LLC · Updated on 2025-11-21
33
Participants Needed
1
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a double-blind, randomized, multisite, placebo-controlled trial comparing the safety and efficacy of TQ versus placebo in patients hospitalized for babesiosis with low risk for relapsing disease who will also be administered a standard-of-care antimicrobial regimen (A/A) that is recommended in the 2020 IDSA guideline on the diagnosis and management of babesiosis.
CONDITIONS
Official Title
Oral Tafenoquine Plus Standard of Care Versus Placebo Plus Standard of Care for Babesiosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, aged 6 18 years.
- Laboratory confirmed infection with Babesia.
- Exhibiting at least one self-reported clinical symptom 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 6 7 g/dL.
You will not qualify if you...
- Have any contraindications to Tafenoquine.
- 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 azithromycin/atovaquone was started more than 48 hours prior to randomization and parasitemia is not greater than 1%.
- Azithromycin or atovaquone administered in the last 12 months to treat babesiosis with a high likelihood of relapse or continued infection, as judged by the investigator.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Actively Recruiting
Research Team
G
Geoff Dow
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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