Abstract
Plasmodium falciparum is said to be yet sensitive to artemether-lumefantrine (AL) among all age groups in Kisumu County, despites report of its isolated strain with reduced sensitivity in Kilifi and reported reduced sensitivity to artemisinins in South East Asia. This trial intended to compare Plasmodium falciparum clearance failure rates among children (6-11 years) with uncomplicated falciparum malaria randomly allocated to artesunate-mefloquine or generic artemether-lumefantrine. We conducted a two arms open label randomized controlled trial with a fourteen day follow up and a sample size of 130 children with uncomplicated falciparum malaria in government primary schools of Kisumu East Sub County. This study showed Plasmodium falciparum clearance failure rates significantly higher (P = 0.02) with generic artemether-lumefantrine than with artesunate-mefloquine on day one of treatment. However, no significant difference (P = 0.999) was observed between the two arms on day seven and day fourteen of treatment. Thus, Plasmodium falciparum was less likely to fail to clear as it responded to artesunate-mefloquine than to generic artemether-lumefantrine on day one of treatment. Nevertheless, it was unlikely to fail to clear as it responded to both artesunate-mefloquine and generic artemether-lumefantrine on day seven and day fourteen of treatment.
Highlights
It was unlikely to fail to clear as it responded to both artesunate-mefloquine and generic artemether-lumefantrine on day seven and day fourteen of treatment
Sensitivity of Plasmodium falciparum to artesunate-mefloquine has been established widely in South East Asia (3), it has not been studied among older children in Kisumu County
Sensitivity was defined as complete clearance of Plasmodium falciparum from the blood of a child (6-11 years) with uncomplicated falciparum malaria, as it responded to either artesunate-mefloquine or generic artemether-lumefantrine, within seven days of treatment with either artesunate-mefloquine or generic artemether-lumefantrine
Summary
Using systematic random sampling technique, 4 government primary schools were selected from a list of government primary schools in Kisumu East Sub County. Six to eleven year old children from pre-school, standards one, two, three and four were screened for Plasmodium falciparum malaria. Due to low prevalence of parasitaemia among children (6-11 years) in some schools, a total of 1300 children were screened in order to be able to achieve the required study sample size. The target population for this study was children (6 - 11 years) in government primary schools in Kisumu East Sub County. Children (6-11 years) in selected government primary schools who had signs of complicated falciparum malaria, allergic to the drugs, history of mental illness or were severely ill or already taking any medicines for malaria were ineligible for this study
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