Abstract
BackgroundIt is recommended that children aged 3 months to five years of age living in areas of seasonal transmission in the sub-Sahel should receive Seasonal Malaria Chemoprevention (SMC) with sulfadoxine-pyrimethamine plus amodiaquine (SPAQ) during the malaria transmission season. The purpose of this study was to evaluate the safety of SMC with SPAQ in children when delivered by community health workers in three districts in Senegal where SMC was introduced over three years, in children from 3 months of age to five years of age in the first year, then in children up to 10 years of age.MethodsA surveillance system was established to record all deaths and all malaria cases diagnosed at health facilities and a pharmacovigilance system was established to detect adverse drug reactions. Health posts were randomized to introduce SMC in a stepped wedge design. SMC with SPAQ was administered once per month from September to November, by nine health-posts in 2008, by 27 in 2009 and by 45 in 2010.ResultsAfter three years, 780,000 documented courses of SMC had been administered. High coverage was achieved. No serious adverse events attributable to the intervention were detected, despite a high level of surveillance.ConclusionsSMC is being implemented in countries of the sub-Sahel for children under 5 years of age, but in some areas the age distribution of cases of malaria may justify extending this age limit, as has been done in Senegal. Our results show that SMC is well tolerated in children under five and in older children. However, pharmacovigilance should be maintained where SMC is implemented and provision for strengthening national pharmacovigilance systems should be included in plans for SMC implementation.Trial RegistrationClinicalTrials.gov NCT 00712374
Highlights
Seasonal Malaria Chemoprevention (SMC) is the administration of a therapeutic dose of antimalarials at monthly intervals to all children, regardless of whether they have malaria infection, to protect them from clinical attacks of malaria during the period of the year when malaria risk is greatest
Our results show that SMC is well tolerated in children under five and in older children
The World Health Organisation (WHO) recommended in March 2012 that children who live in areas of highly seasonal malaria transmission in the Sahel and sub-Sahel regions should receive SMC with sulfadoxine-pyrimethamine plus amodiaquine (SPAQ) administered monthly for up to four months of the year during the period when children are at greatest risk of malaria [2,3]
Summary
Seasonal Malaria Chemoprevention (SMC) is the administration of a therapeutic dose of antimalarials at monthly intervals to all children, regardless of whether they have malaria infection, to protect them from clinical attacks of malaria during the period of the year when malaria risk is greatest. The World Health Organisation (WHO) recommended in March 2012 that children who live in areas of highly seasonal malaria transmission in the Sahel and sub-Sahel regions should receive SMC with SPAQ administered monthly for up to four months of the year during the period when children are at greatest risk of malaria [2,3]. It is recommended that children aged 3 months to five years of age living in areas of seasonal transmission in the sub-Sahel should receive Seasonal Malaria Chemoprevention (SMC) with sulfadoxine-pyrimethamine plus amodiaquine (SPAQ) during the malaria transmission season. The purpose of this study was to evaluate the safety of SMC with SPAQ in children when delivered by community health workers in three districts in Senegal where SMC was introduced over three years, in children from 3 months of age to five years of age in the first year, in children up to 10 years of age
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