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Anti-parasitic

Tafenoquine for Babesiosis

Phase 2
Recruiting
Research Sponsored by 60 Degrees Pharmaceuticals LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Exhibiting at least one self-reported clinical symptom of babesiosis
Able to take oral medications
Must not have
Taking any excluded concomitant medication
Current or planned treatment with quinine while participating in the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to 90

Summary

This trial will test if a medication called TQ is safe and effective for treating babesiosis in patients who are hospitalized. The study will compare TQ to a placebo in patients who are at low risk

Who is the study for?
Adults hospitalized for babesiosis who can take oral meds, have good vein access for blood draws, and agree to birth control if of reproductive age. They must not join other drug studies simultaneously, be confirmed with Babesia infection showing symptoms, and consent to study requirements.
What is being tested?
The trial tests Tafenoquine (TQ) plus standard care against a placebo plus standard care in patients with babesiosis. It's double-blind (neither doctors nor patients know who gets what), randomized (assigned by chance), at multiple sites, and checks safety and effectiveness.
What are the potential side effects?
Potential side effects are not specified here but would typically relate to the known side effects of Tafenoquine when treating malaria-like conditions: gastrointestinal issues, headache, dizziness, or changes in blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am experiencing symptoms of babesiosis.
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I can take pills by mouth.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not on any medication that is not allowed in the study.
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I am currently taking or will start taking quinine during the study.
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I am allergic or cannot take azithromycin or atovaquone.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to 90
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to 90 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time to sustained clinical resolution
Secondary study objectives
Difference in TTMC between TQ and placebo

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Group 1Active Control1 Intervention
TQ: 2 x 100 mg TQ tablets orally on Days 1, 2, 3, and 4
Group II: Group 2Placebo Group1 Intervention
Placebo: 2 x 100 mg placebo tablets orally on Days 1, 2, 3, and 4

Find a Location

Who is running the clinical trial?

60 Degrees Pharmaceuticals LLCLead Sponsor
5 Previous Clinical Trials
726 Total Patients Enrolled
2 Trials studying Babesiosis
40 Patients Enrolled for Babesiosis
~12 spots leftby Mar 2025
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