๐ฌIn plain words
What the trial is, and whether it could suit you
Phase 2 Open Label Study of Tafenoquine for Treatment of Chronic Babesiosis Patients with Severe Fatigue
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* Male or female, aged โฅ 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 โค 8 g/dL
Icahn School of Medicine at Mount Sinai
New York, United States
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.