single low dose tafenoquine to reduce p. falciparum transmission in mali (nectar2)

Conditions: Malaria, Falciparum

Summary: the purpose of this study is to assess the gametocytocidal and transmission reducing activity of dihydroartemisinin-piperaquine (dp) with and without various low doses of tafenoquine (tq; 1.66mg/kg, 0.83mg/kg, or 0.415mg/kg). outcome measures will include infectivity to mosquitoes at 2 and 7 days after treatment, gametocyte density throughout follow-up, and safety measures including haemoglobin density.

full protocol available on request.

Eligibility criteria:
inclusion criteria: * age ≥ 12 years and ≤ 50 years * glucose 6 phosphate dehydrogenase (g6pd) normal status defined by carestart rapid diagnostic test or the g6pd qualitative test (osmmr2000) * absence of symptomatic falciparum malaria, defined by fever on enrolment * presence of p. falciparum gametocytes on thick blood film at a density \>16 gametocytes/µl (i.e. ≥ gametocytes recorded in the thick film against 500 white blood cells) * absence of other non-p. falciparum species on blood film * no allergies to study drugs * no use of antimalarial drugs over the past 7 days (as reported by the participant) * hemoglobin ≥ 10 g/dl * individuals weighing \< = 80 kg * no evidence of acute severe or chronic disease * written, informed consent exclusion criteria: * age \ 50 years * women who are pregnant or lactating * blood thick film negative for sexual stages of malaria * detection of a non-p. falciparum species by microscopy * previous reaction to study drugs / known allergy to study drugs * signs of severe malaria, including hyperparasitemia (defined as asexual parasitemia \> 100,000 parasites / µl) * signs of acute or chronic illness, including hepatitis * the use of other medication (with the exception of paracetamol and/or aspirin) * consent not given * g6pd-deficiency by carestart rapid diagnostic test or the osmmr2000 g6pd qualitative test * use of antimalarial drugs over the past 7 days (as reported by the participant) * the use of other medication (with the exception of paracetamol and/or aspirin) * clinically significant illness (intercurrent illness e.g. pneumonia, pre-existing condition e.g. renal disease, malignancy or conditions that may affect absorption of study medication e.g. severe diarrhea or any signs of malnutrition as defined clinically) * signs of hepatic injury (such as nausea and/or abdominal pain associated with jaundice) or known severe liver disease (i.e. decompensated cirrhosis, child pugh stage b or c) * signs, symptoms or known renal impairment * clinically significant abnormal laboratory values as determined by history, physical examination or routine blood chemistries and hematology values (laboratory guideline values for exclusion are hemoglobin \ 2.0mg/dl, or alt or ast more than 3 times the upper limit of normal for age. * family history of diseases leading to qt prolongation or recent treatment with drugs linked to qt prolongation * blood transfusion in the last 90 days. * consistent with the long half-life of tafenoquine, effective contraception should be continued for 5 half-lives (3 months) after the end of treatment. * history of psychiatric disorders