title: Safety of Seasonal Malaria Chemoprevention (SMC) with Sulfadoxine-Pyrimethamine plus Amodiaquine when Delivered to Children under 10 Years of Age by District Health Services in Senegal: Results from a Stepped-Wedge Cluster Randomized Trial.
abstract: BACKGROUND
  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, then in children up to 10 years of age.
  
  
  METHODS
  A 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.
  
  
  RESULTS
  After 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.
  
  
  CONCLUSIONS
  SMC 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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT 00712374.
authors.affiliation: Department of Parasitology, University Cheikh Anta Diop, Dakar, Senegal.
authors.forename: J L
authors.initials: JL
authors.lastname: NDiaye
authors.affiliation: Department of Parasitology, University Cheikh Anta Diop, Dakar, Senegal.|Institut Pasteur, Antananarivo, Madagascar.
authors.forename: B
authors.initials: B
authors.lastname: Cissé
authors.affiliation: Institut de Recherche pour le Développement, Dakar, Sénégal.
authors.forename: E H
authors.initials: EH
authors.lastname: Ba
authors.affiliation: Institut de Recherche pour le Développement, Dakar, Sénégal.
authors.forename: J F
authors.initials: JF
authors.lastname: Gomis
authors.affiliation: Department of Parasitology, University Cheikh Anta Diop, Dakar, Senegal.
authors.forename: C T
authors.initials: CT
authors.lastname: Ndour
authors.affiliation: Institut de Recherche pour le Développement, Dakar, Sénégal.
authors.forename: J F
authors.initials: JF
authors.lastname: Molez
authors.affiliation: National Malaria Control Program, Ministry of Health and Prevention, Dakar, Senegal.
authors.forename: F B
authors.initials: FB
authors.lastname: Fall
authors.affiliation: Institut de Recherche pour le Développement, Dakar, Sénégal.
authors.forename: C
authors.initials: C
authors.lastname: Sokhna
authors.affiliation: Department of Parasitology, University Cheikh Anta Diop, Dakar, Senegal.
authors.forename: B
authors.initials: B
authors.lastname: Faye
authors.affiliation: Institut de Recherche pour le Développement, Dakar, Sénégal.
authors.forename: E
authors.initials: E
authors.lastname: Kouevijdin
authors.affiliation: Department of Parasitology, University Cheikh Anta Diop, Dakar, Senegal.
authors.forename: F K
authors.initials: FK
authors.lastname: Niane
authors.affiliation: London School of Hygiene &Tropical Medicine, London, United Kingdom.
authors.forename: M
authors.initials: M
authors.lastname: Cairns
authors.affiliation: Institut de Recherche pour le Développement, Dakar, Sénégal.
authors.forename: J F
authors.initials: JF
authors.lastname: Trape
authors.affiliation: Institut Pasteur, Antananarivo, Madagascar.
authors.forename: C
authors.initials: C
authors.lastname: Rogier
authors.affiliation: Department of Parasitology, University Cheikh Anta Diop, Dakar, Senegal.
authors.forename: O
authors.initials: O
authors.lastname: Gaye
authors.affiliation: London School of Hygiene &Tropical Medicine, London, United Kingdom.
authors.forename: B M
authors.initials: BM
authors.lastname: Greenwood
authors.affiliation: London School of Hygiene &Tropical Medicine, London, United Kingdom.
authors.forename: P J M
authors.initials: PJ
authors.lastname: Milligan
mesh_terms: D000655:Amodiaquine / Q000009:adverse effects / Q000627:therapeutic use*; D000962:Antimalarials / Q000009:adverse effects / Q000627:therapeutic use*; D018890:Chemoprevention; D002648:Child; D002675:Child, Preschool; D004338:Drug Combinations; D004359:Drug Therapy, Combination; D005260:Female; D006296:Health Services; D006760:Hospitalization; D006801:Humans; D007223:Infant; D007565:Jaundice / Q000209:etiology; D008288:Malaria / Q000453:epidemiology / Q000401:mortality / Q000517:prevention & control*; D008297:Male; D011739:Pyrimethamine / Q000009:adverse effects / Q000627:therapeutic use*; D012621:Seasons; D012675:Senegal / Q000453:epidemiology; D013413:Sulfadoxine / Q000009:adverse effects / Q000627:therapeutic use*; D016019:Survival Analysis
chemical_list: D000962:Antimalarials; D004338:Drug Combinations; D000655:Amodiaquine; C001205:fanasil, pyrimethamine drug combination; D013413:Sulfadoxine; D011739:Pyrimethamine