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โ† Trials
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Oral Tafenoquine Plus Standard of Care Versus Placebo Plus Standard of Care for Babesiosis

RecruitingPhase 2Ages 18 Years - anyAll60 Degrees Pharmaceuticals LLC
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Male or female, aged โ‰ฅ 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 โ‰ฅ 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.
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What it tests

  • Tafenoquine
  • Placebo
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Where

1 site
Tufts Medical Center
Boston, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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