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

Study Overview

• Status: Not yet recruiting
• Conditions: Babesiosis
• Intervention / Treatment: Other: Placebo; Drug: Tafenoquine

Detailed Description

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.

Patients hospitalized for a diagnosis of babesiosis, who have received A/A for <48 hours (h) prior to randomization or are about to receive A/A, will be asked to provide written informed consent and will undergo eligibility screening including medical history, physical examination, prior and concomitant medications, blood chemistry and hematology, glucose-6-phosphate dehydrogenase (G6PD) deficiency testing, blood smear for diagnostic confirmation of babesiosis, pregnancy testing for females of child-bearing potential, and assessment of risk factors for relapsing babesiosis. The screening period will last a maximum of two days. The first day of dosing with TQ or placebo will be Day 1 and will be done while the patient is still hospitalized.

• Study Type: Interventional
• Enrollment (Estimated): 33
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Geoff Dow; Phone Number: 202-327-5422; Email: geoffdow@60degreespharma.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; TQ: 2 x 100 mg TQ tablets orally on Days 1, 2, 3, and 4	Drug: Tafenoquine; Oral Tafenoquine
Placebo Comparator: Group 2; Placebo: 2 x 100 mg placebo tablets orally on Days 1, 2, 3, and 4	Other: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in TTMC between TQ and placebo	Difference in TTMC between TQ and placebo from Day 1 to Day 90 (± 7 days). Molecular cure is defined as the time to the first instance of a negative NAT.	Day 1 to 90

Collaborators and Investigators

• Sponsor: 60 Degrees Pharmaceuticals LLC

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: December 21, 2023
• First Submitted That Met QC Criteria: January 4, 2024
• First Posted (Actual): January 17, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: babesiosis
• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections, Animal; Parasitic Diseases, Animal; Protozoan Infections; Tick-Borne Diseases; Babesiosis; Anti-Infective Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Tafenoquine
• Other Study ID Numbers: TQ-BA-2024-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No