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RecruitingPhase 2NCT06207370

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

Sponsor

60 Degrees Pharmaceuticals LLC

Enrollment

33 participants

Start Date

Jun 17, 2024

Study Type

INTERVENTIONAL

Conditions

Babesiosis

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria11

  • 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 Criteria9

  • 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.

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Interventions

DRUGTafenoquine

Oral Tafenoquine

OTHERPlacebo

Placebo

Locations(1)

Tufts Medical Center

Boston, Massachusetts, United States

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NCT06207370