RECRUITING

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

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Conditions

Babesiosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2024-06-17
Study Completion:2025-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06207370

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female, aged ≥ 18 years.
  2. * Laboratory confirmed infection with Babesia.
  3. * Exhibiting at least one self-reported clinical symptoms of babesiosis.
  4. * Able and willing to give written informed consent.
  5. * 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.
  6. * Willing to complete the study activities and assessments.
  7. * Must agree not to enroll in another study of an investigational agent prior to completion of the study.
  8. * Able to take oral medications.
  9. * If female of reproductive age, must agree to use an acceptable method of birth control.
  10. * Adequate venous access.
  11. * Blood hemoglobin ≥ 7 g/dL.
  1. * Have any contraindications to TQ.
  2. * Have any contraindication for azithromycin or atovaquone.
  3. * Any concomitant significant illness unrelated to babesiosis.
  4. * Receipt of any experimental treatment for babesiosis.
  5. * Taking any excluded concomitant medication.
  6. * Current or planned treatment with quinine while participating in the study.
  7. * Positive pregnancy test.
  8. * If A/A was initiated more than 48h prior to randomization and parasitemia is not \>1%.
  9. * 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

Study Contact

Geoff Dow
CONTACT
202-327-5422
geoffdow@60degreespharma.com

Study Locations (Sites)

Tufts Medical Center
Boston, Massachusetts, 02111
United States

Collaborators and Investigators

Sponsor: 60 Degrees Pharmaceuticals LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-17
Study Completion Date2025-07-01

Study Record Updates

Study Start Date2024-06-17
Study Completion Date2025-07-01

Terms related to this study

Keywords Provided by Researchers

  • babesiosis

Additional Relevant MeSH Terms

  • Babesiosis