Malaria
Conditions
Interventions
Artemether-lumefantrine (20/80 mg artemether and 120/480 mg lumefantrine), Primaquine Phosphate (0.25mg/kg), Sulphadoxine-pyrimethamine with amodiaquine (500mg sulfadoxine and 25mg pyrimethamine and 1
Sponsors
London School of Hygiene and Tropical Medicine
Eligibility
Inclusion criteria
Inclusion criteria: - Age = 10 years and = 50 years - G6PD-normal defined by Carestart rapid diagnostic test or the OSMMR2000 G6PD qualitative test - 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 - Hemoglobin = 10 g/dL - Individuals weighing < = 80 kg - No evidence of acute severe or chronic disease - Written, informed consent
Exclusion criteria
Exclusion criteria: - Women who are pregnant or lactating (tested at baseline). Urine and/or serum pregnancy testing (ß-hCG) will be used. - 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 (except for paracetamol and/or aspirin) - Use of antimalarial drugs over the past 7 days (as reported by the participant) - 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. - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in mosquito infection rate assessed through membrane feeding assays (day 2 and day 7) Within person percent change (presented as percent reduction) in mosquito infection rate in infectious individuals from baseline (day 0, pre-treatment) to day 2 post treatment in the AL and AL-PQ arms, and day 7 post-treatment in the SPAQ and SPAQ-TQ. [Time Frame: 3 days (days 0, 2 and 7): 7 day span] | — |
Secondary
| Measure | Time frame |
|---|---|
| 2. Change in mosquito infection rate assessed through membrane feeding assays (all timepoints) Within person percent change (presented as percent reduction) in mosquito infection rate from baseline to all feeding time-points, with comparison within and between arms. [Time Frame: 7 days (day 0, day 2, day 5, day 7, day 14, day 21, day 28): 28 day span] 3. Mosquito infection rate assessed through membrane feeding assays Mosquito infection rate at all feeding time-points, with comparison within treatment arms compared to baseline, and between arms. [Time Frame: 7 days (day 0, day 2, day 5, day 7, day 14, day 21, day 28): 28 day span] 4. Human infectivity to locally reared mosquitoes assessed through membrane feeding assays Infectivity to mosquitoes at all feeding time-points, with comparison within treatment arms compared to baseline, and between arms. [Time Frame: 7 days (day 0, day 2, day 5, day 7, day 14, day 21, day 28): 28 day span] 5.Mosquito infection density assessed through membrane feeding assays Oocyst intensity (in all/all infected mosquitoes) at all feeding time-points, with comparison within treatment arms compared to baseline, and between arms. [Time Frame: 7 days (day 0, day 2, day 5, day 7, day 14, day 21, day 28): 28 day span] 6. Gametocyte infectivity Infectiousness to mosquitoes for a given gametocyte density (measured as mosquito infection rate/gametocyte) at all feeding time-points, with comparison within treatment arms compared to baseline, and between arms. [Time Frame: 7 days (day 0, day 2, day 5, day 7, day 14, day 21, day 28): 28 day span] 7. Asexual/sexual stage parasite prevalence Male and female gametocyte prevalence at all time-points, determined by microscopy or molecular assays, with comparison within treatment arms compared to baseline, and between arms. Asexual and total parasite prevalence at all time-points, determined by microscopy or molecular assays, with comparison within treatment arms compared to baseline, and betwe | — |
Contacts
Public ContactMerel Smit
Radboud university medical center
Outcome results
None listed