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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

NCT00119132 Phase 2/Phase 3 COMPLETED

Intermittent preventive treatment for malaria in children (IPTc) is a promising new approach to malaria control. Preliminary studies of IPTc in Senegal and Mali indicate that this approach can be very effective. Although the results of these studies suggest that IPTc with sulphadoxine-pyrimethamine (SP) plus artesunate (AS) or SP alone is an efficacious and safe intervention for reducing the burden of malaria and anaemia in children in high transmission areas with short transmission periods, there is no data from areas with long transmission periods. This study aims to evaluate the effectiveness of IPTc in reducing anaemia and malaria in an area with up to 6 months of transmission in Ghana. Two thousand two hundred forty children aged 3-59 months will be randomly allocated to four groups (560 per arm) to receive amodiaquine plus artesunate (AQ+AS), given at two different intervals (monthly or bimonthly), SP or placebo. The children will also be followed to determine if there is any rebound in the incidence of severe malaria and anaemia in the year following IPTc.

Details

Lead sponsorLondon School of Hygiene and Tropical Medicine
PhasePhase 2/Phase 3
StatusCOMPLETED
Enrolment2602
Start date2005-06
Completion2006-12

Conditions

Interventions

Primary outcomes

Countries

Ghana