Malaria Clinical Trial
Official title:
A Double Blind Randomized Controlled Trial to Assess the Efficacy and Safety of Low Dose Primaquine for Clearance of Gametocytes in Asymptomatic Individuals Infected With P. Falciparum in Burkina Faso
Primaquine (PQ) is currently the only available drug that can clear mature transmission
stages of P. falciparum parasites. PQ was previously shown to clear gametocytes that persist
after artemisinin-combination therapy. However, there are safety concerns about the use of
PQ at the currently recommended dose of 0.75mg/kg in individuals who are glucose-6-phosphate
dehydrogenase (G6PD) deficient. PQ causes transient but significant haemolysis in G6PD
deficient individuals; this side-effect is dose dependent. There are indications that a
lower dosing of PQ may effectively reduce gametocyte carriage but the lowest efficacious
dose for gametocyte clearance is currently unknown. Recently, the World Health Organization
changed their recommendation to a low dose of primaquine, 0.25mg/kg. However, there is no
direct evidence on the extent to which (low dose) PQ prevents malaria transmission to
mosquitoes and what the lowest efficacious dose is.
In the current study we aim to identify the lowest efficacious dose of PQ in individuals
with normal G6PD function. Children with asymptomatic malaria and normal G6PD enzyme
function will be randomized to treatment with artemether-lumefantrine alone or in
combination with low doses of PQ. All enrolled individuals will receive a full three-day
course of AL, and will be randomized to receive a dose of primaquine or placebo with their
fifth dose of AL. Efficacy will be determined based on gametocyte carriage during follow-up,
measured by molecular methods. For a subset of participants with patent gametocytes,
primaquine effect on infectivity to mosquitoes will be assessed by membrane feeding assays
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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