Tafenoquine for Babesiosis
(TQ-BA-2024-3 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the effectiveness of the drug tafenoquine in treating chronic babesiosis, a condition that often causes severe fatigue, chills, and muscle aches. Participants will self-administer the medication over a 12-week period to assess its impact on symptoms. The trial seeks individuals who have experienced severe fatigue and have evidence of babesiosis exposure in the past year. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently or planning to be treated with quinine or taking certain medications without proper medical oversight. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that tafenoquine is likely to be safe for humans?
Previous studies have led to FDA approval of tafenoquine for preventing malaria, demonstrating its safety for that use. However, the FDA has not yet approved it for treating babesiosis. Research on tafenoquine for babesiosis continues.
Tafenoquine has been combined with other treatments for babesiosis. Although limited safety information exists for its use in babesiosis, its approval for malaria suggests it is generally well-tolerated. Studies on babesiosis are still underway, and more information will clarify its safety for this condition.12345Why do researchers think this study treatment might be promising?
Tafenoquine is unique because it offers a new approach to treating babesiosis. Unlike the standard treatments like atovaquone or azithromycin, which often require frequent dosing, tafenoquine is taken less frequently, potentially improving patient adherence. Additionally, tafenoquine has a long half-life, which might provide a more sustained action against the parasites causing the disease. Researchers are excited about its potential to simplify the treatment regimen while maintaining effectiveness.
What evidence suggests that tafenoquine might be an effective treatment for babesiosis?
Research has shown that tafenoquine holds promise for treating babesiosis. In this trial, participants will receive tafenoquine alone. Studies have found that tafenoquine, when used by itself, effectively eliminates drug-resistant strains of Babesia in lab tests. Another study discovered that combining tafenoquine with atovaquone completely cured human babesiosis in models, with no return of the parasite. These findings suggest tafenoquine could help with chronic babesiosis that causes severe tiredness. Overall, the evidence supports tafenoquine's potential to treat this condition.36789
Are You a Good Fit for This Trial?
This trial is for individuals who have been diagnosed with chronic babesiosis and are experiencing severe disabling fatigue. Participants must be able to consent, perform all study assessments, and if female, not be pregnant and agree to use birth control.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants self-administer Tafenoquine orally with food on Days 1, 2, 3, 4, then weekly thereafter for a total 12-week treatment period
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Tafenoquine
Find a Clinic Near You
Who Is Running the Clinical Trial?
60 Degrees Pharmaceuticals LLC
Lead Sponsor