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
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.
• 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.