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

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 female of reproductive age, must agree to use an acceptable method of birth control.
* Adequate venous access.
* Blood hemoglobin ≥ 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.