60 Degrees Pharmaceuticals LLC
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.
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…
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…
Oral Tafenoquine
Placebo
Arctuva estimate
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