Comparing Tafenoquine with Placebo for Treating Babesiosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a double-blind, randomized, multisite, placebo-controlled study that evaluates the safety and efficacy of Tafenoquine (TQ) in patients hospitalized for babesiosis who are at low risk for relapsing disease. Participants will receive either TQ or a placebo in addition to a standard antimicrobial regimen recommended by the 2020 IDSA guidelines. Eligible patients must be hospitalized and have a confirmed diagnosis of babesiosis, and they will undergo thorough screening before randomization. The study aims to determine if TQ can improve outcomes compared to placebo in this patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Tufts Medical Center
  Boston, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Geoff Dow
• Email: geoffdow@60degreespharma.com
• Phone: 202-327-5422

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Tick-borne infections in Finland: a broad, multicenter look at Lyme, TBE and other infections

  This study tests how common and how these infections show up in people with suspected tick-borne disease in Finland.

  Recruiting at 2 sites Turku University Hospital · Helsinki and 2 other locations · NCT07897825

• Tafenoquine treatment for chronic babesiosis with severe fatigue

  This open-label Phase 2 trial tests tafenoquine 100 mg to see if it reduces severe fatigue and other symptoms in adults with chronic babesiosis who have laboratory evidence of recent Babesia exposure.

  Recruiting Phase 2 60 Degrees Pharmaceuticals LLC · New York, New York · NCT06656351

• Babesiosis cases across metropolitan France

  This project will collect and review data to see how babesiosis affects adults diagnosed and treated in French hospitals between 2000 and 2024.

  Recruiting University Hospital, Strasbourg, France · Strasbourg · NCT07345988

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.