Oral Tafenoquine Plus Standard of Care Versus Placebo Plus Standard of Care for Babesiosis

NCT06207370 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: TQ-BA-2024-1
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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

Keywords

babesiosis

Outcome Measures

Primary Outcomes (1)

• Time to sustained clinical resolution

  Time to sustained clinical resolution of all the following symptoms of babesiosis: sweats, joint aches, cough, loss of appetite, muscle aches, headache, chills or shivering, feeling hot or feverish, nausea, fatigue (low energy or tiredness), and vomiting. The time to achieve sustained clinical resolution will be the date when patients first self-report a 7-day period without these symptoms relative to the start of tafenoquine or placebo treatment.

  Day 1 to 90

Secondary Outcomes (1)

• Difference in TTMC between TQ and placebo

  Day 1 to 90

Study Arms (2)

Group 1

ACTIVE COMPARATOR

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

Drug: Tafenoquine

Group 2

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Tafenoquine DRUG

Oral Tafenoquine

Group 1

Placebo OTHER

Placebo

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• 60 Degrees Pharmaceuticals LLC: lead

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

RECRUITING

MeSH Terms

Conditions

Babesiosis

Interventions

tafenoquine

Condition Hierarchy (Ancestors)

Protozoan Infections, Animal; Parasitic Diseases, Animal; Parasitic Diseases; Infections; Protozoan Infections; Tick-Borne Diseases; Vector Borne Diseases; Animal Diseases

Central Study Contacts

Geoff Dow

CONTACT

202-327-5422; geoffdow@60degreespharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 17, 2024
• Study Start: June 17, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)