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
60 Degrees Pharmaceuticals LLC
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.
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 eligib…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 fe…
Interventions
- DrugTafenoquine
Oral Tafenoquine
- OtherPlacebo
Placebo
Location
- Tufts Medical CenterBoston, Massachusetts