Status:
RECRUITING
Oral Tafenoquine Plus Standard of Care Versus Placebo Plus Standard of Care for Babesiosis
Lead Sponsor:
60 Degrees Pharmaceuticals LLC
Conditions:
Babesiosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT06207370
Start Date
June 17 2024
End Date
July 1 2027
Last Update
November 21 2025
Active Locations (1)
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1
Tufts Medical Center
Boston, Massachusetts, United States, 02111