B-FREE Chronic Babesiosis Study
Phase 2 Open Label Study of Tafenoquine for Treatment of Chronic Babesiosis Patients with Severe Fatigue
Study identifier: NCT06656351. Status: RECRUITING. Phase: PHASE2.
Eligibility
Criteria: Inclusion Criteria: * Male or female, aged ≥ 18 years * Severe disabling fatigue * Have at least one common symptom of babesiosis * Have laboratory evidence of exposure to babesia in the last 12 months * Able and willing to give written informed consent * Able and willing to perform all study assessments * If female negative urine pregnancy test and * If female agree to use an acceptable method of birth control Exclusion Criteria: * Glucose-6-phosphate-dehydrogenase (G6PD) deficiency * Breastfeeding * Unmanaged Psychotic disorder * Known hypersensitivity reaction to tafenoquine or other 8-aminoquinolines * Current or planned treatment with quinine * Uncontrolled cardiopulmonary or endocrine disorders * Taking OCT2/MATE substrates without appropriate medical oversight * Medical history of chronic, active viral diseases including HIV/AIDS, hepatitis B, and hepatitis C * Have a risk factors for relapsing babesiosis * Anorexia * Any concomitant significant illness unrelated to babesiosis * The patient is unable to tolerate medication by the oral route * The patient has previously taken tafenoquine * Hemoglobin at baseline is ≤ 8 g/dL
- Minimum age: 18 Years
Participating locations
- Icahn School of Medicine at Mount Sinai, New York, New York
Study records are sourced from ClinicalTrials.gov. Confirm current eligibility, recruiting status, and locations in the official record.