Comparing Tafenoquine with Placebo for Treating Babesiosis

A Double-blind Placebo-controlled Study to Assess the Safety and Efficacy of Oral Tafenoquine Plus Standard of Care Versus Placebo Plus Standard of Care in Patients Hospitalized for Babesiosis

This study is testing if a new medication called Tafenoquine can help hospitalized patients with babesiosis get better compared to a placebo.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: 60 Degrees Pharmaceuticals LLC (Industry-sponsored)
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT06207370 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have a laboratory-confirmed infection with Babesia and are currently hospitalized.

Not a fit: Patients with contraindications to Tafenoquine or those receiving experimental treatments for babesiosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from babesiosis.

How similar studies have performed: While this approach is novel in the context of babesiosis treatment, similar studies have shown promise in evaluating new therapies for infectious diseases.

Eligibility criteria

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 this trial is running

Boston, Massachusetts

• Tufts Medical Center — Boston, Massachusetts, United States (Recruiting)

Study contacts

• Study coordinator: Geoff Dow

Conditions Babesiosis; babesiosis