Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT06656351
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06656351
Study Brief:
Protocol Section:
NCT06656351