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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06207370
Recruitment Status : Not yet recruiting
First Posted : January 17, 2024
Last Update Posted : March 15, 2024
Sponsor:
Information provided by (Responsible Party):
60 Degrees Pharmaceuticals LLC

Study Description
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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.

Condition or disease Intervention/treatment Phase
Babesiosis Drug: Tafenoquine Other: Placebo Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double blind
Primary Purpose: Treatment
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
Estimated Study Start Date : May 1, 2024
Estimated Primary Completion Date : March 1, 2025
Estimated Study Completion Date : July 1, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06207370


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

Sponsors and Collaborators
60 Degrees Pharmaceuticals LLC
More Information
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Responsible Party: 60 Degrees Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT06207370    
Other Study ID Numbers: TQ-BA-2024-1
First Posted: January 17, 2024    Key Record Dates
Last Update Posted: March 15, 2024
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by 60 Degrees Pharmaceuticals LLC:
babesiosis
Additional relevant MeSH terms:
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Babesiosis
Protozoan Infections, Animal
Parasitic Diseases, Animal
Parasitic Diseases
Infections
Protozoan Infections
Tick-Borne Diseases
 Vector Borne Diseases
Tafenoquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents