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

• ClinicalTrials.gov Identifier: NCT06207370
• Recruitment Status: Not yet recruiting
• First Posted: January 17, 2024
• Last Update Posted: March 15, 2024
• Sponsor: 60 Degrees Pharmaceuticals LLC
• Information provided by (Responsible Party): 60 Degrees Pharmaceuticals LLC

Tracking Information

• First Submitted Date: December 21, 2023
• First Posted Date: January 17, 2024
• Last Update Posted Date: March 15, 2024
• Estimated Study Start Date: May 1, 2024
• Estimated Primary Completion Date: March 1, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 14, 2024)

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

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.

Original Primary Outcome Measures (submitted: January 4, 2024)

Difference in TTMC between TQ and placebo [ Time Frame: Day 1 to 90 ]

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.

Current Secondary Outcome Measures (submitted: March 14, 2024)

Difference in TTMC between TQ and placebo [ Time Frame: Day 1 to 90 ]

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.

Original Secondary Outcome Measures (submitted: January 4, 2024)

• Time to sustained clinical resolution [ Time Frame: Day 1 to 90 ]
  Time to sustained clinical resolution (at least one week) of all the following symptoms (collectively and individually) through Day 90 (± 7 days): Fever, fatigue, sweats, muscle ache, headache, chills, anorexia, neck stiffness, emotional lability, cough, shortness of breath, nausea, joint pain, sore throat, vomiting, conjunctivitis, joint swelling, dark urine, and splenomegaly.
• Proportion of patients in each arm with any clinical symptom of babesiosis [ Time Frame: Day 1 to 90 ]
  Proportion of patients in each arm with any clinical symptom of babesiosis at each assessment, maximum severity of any symptoms at each assessment, and proportion and maximum severity by symptom at each assessment.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Oral Tafenoquine Plus Standard of Care Versus Placebo Plus Standard of Care for Babesiosis
• Official Title: 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
• 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.

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
• Study Phase: Phase 2

Study Design

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

Double blind

Primary Purpose: Treatment

• Condition: Babesiosis

Intervention

• Drug: Tafenoquine
  Oral Tafenoquine
• Other: Placebo
  Placebo

Study Arms

• Active Comparator: Group 1
  TQ: 2 x 100 mg TQ tablets orally on Days 1, 2, 3, and 4
  Intervention: Drug: Tafenoquine
• Placebo Comparator: Group 2
  Placebo: 2 x 100 mg placebo tablets orally on Days 1, 2, 3, and 4
  Intervention: Other: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: March 14, 2024): 33
• Original Estimated Enrollment (submitted: January 4, 2024): 30
• Estimated Study Completion Date: July 1, 2025
• Estimated Primary Completion Date: March 1, 2025 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Geoff Dow; 202-327-5422; geoffdow@60degreespharma.com

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT06207370
• Other Study ID Numbers: TQ-BA-2024-1
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: 60 Degrees Pharmaceuticals LLC
• Original Responsible Party: Same as current
• Current Study Sponsor: 60 Degrees Pharmaceuticals LLC
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: 60 Degrees Pharmaceuticals LLC
• Verification Date: December 2023