Recruiting
Phase 2

Tafenoquine

Sponsor:

60 Degrees Pharmaceuticals LLC

Code:

NCT06207370

Conditions

Babesiosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tafenoquine

Placebo

Study Details

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 disease who will also be administered a standard-of-care antimicrobial regimen (A/A) that is recommended in the 2020 IDSA guideline on the diagnosis and management of babesiosis.

Conditions

Babesiosis

Study ID

NCT06207370

Start date

Jun 17, 2024

Status verified date

Nov, 2025

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

33 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Group 1

TQ: 2 x 100 mg TQ tablets orally on Days 1, 2, 3, and 4

placebo comparator: Group 2

Placebo: 2 x 100 mg placebo tablets orally on Days 1, 2, 3, and 4

Interventions

Tafenoquine

Oral Tafenoquine

Placebo

Placebo

Primary outcome measure

  • Time to sustained clinical resolution [ Time Frame: Day 1 to 90 ]

Central Contacts and Locations

Central contacts

Geoff Dow

202-327-5422geoffdow@60degreespharma.com

Locations

Tufts Medical Center

Recruiting

Boston, Massachusetts, United States, 02111

Contacts

Lauren Tobias

Lauren.E.Tobias@tuftsmedicine.org

Principal Investigator:

Whitney Perry, MD

More Information

Sponsor

60 Degrees Pharmaceuticals LLC

Last update posted

Nov 21, 2025

Last verified

Nov, 2025

Keywords

  • babesiosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by 60 Degrees Pharmaceuticals LLC on 2025-11-21.