A Study Of Impact Of Intermittent Preventive Treatment In Children With Amodiaquine Plus Artesunate Versus Sulphadoxine-Pyrimethamine On Hemoglobin Levels And Malaria Morbidity In Hohoe District Of Ghana

Background:

In high transmission areas, where a major proportion of deaths and severe morbidity from malaria occurs during the first year of life, intermittent preventive treatment for infants (IPTi) could make a major contribution to reducing the burden of malaria as a whole. However, in many areas in Africa, where mortality and morbidity from malaria in children under five years of age is very high and the burden of malaria is not predominantly in infants, IPTi, even if highly effective, would have only a limited impact on the overall burden of malaria in children.

Few community trials have evaluated the effect of IPTc in the prevention of malaria. Dicko and his colleagues in Mali, an area of seasonal malaria transmission gave two doses of SP to children aged 6 months to 9 years at an interval of two months and found a protective efficacy of 40% against clinical attacks of malaria among children in the intervention group compared to the placebo group. Recent work in Niakhar, Senegal has assessed IPTc in an area of intense but short seasonal malaria transmission. The study used a combination of SP plus one dose of AS, which was given every month for three months during the rainy season which lasted for only four months. This study showed that IPTc using AS+SP was well tolerated without any drug-attributable adverse events and that IPTc can reduce the incidence of clinical malaria by 86%. Although these results suggest that IPTc with SP+one dose of AS is an efficacious and safe intervention for reducing the burden of malaria and anaemia in children, there is no data on the effectiveness of IPTc in areas with prolonged transmission seasons and on the use of other forms of combination therapy in IPTc.

Study overview:

The study aims to determine the optimum drug schedule for IPTc in an area of prolonged seasonal malaria transmission in Ghana. The main study will compare the effectiveness of IPTC using SP, monthly AQ+AS or bimonthly AQ+AS. In order to facilitate the interpretation of the results of this trial, two ancillary studies will be done. The first will be a conventional in vivo drug efficacy study of SP and AQ+AS in children with clinical malaria to ensure the efficacy of the drugs used in the IPTc trial within the study area. The second subsidiary study will be an investigation of whether or not administration of IPTc over one malaria transmission season is followed by an increase in the incidence of malaria or anaemia during the following malaria transmission season.