@article{fdi:010068292, title = {{S}afety of {S}easonal {M}alaria {C}hemoprevention ({SMC}) with sulfadoxine-pyrimethamine plus amodiaquine when delivered to children under 10 years of age by district health services in {S}enegal : results from a stepped-wedge cluster randomized trial}, author = {{N}diaye, {J}. {L}. and {C}iss{\'e}, {B}. and {B}a, {E}. {H}. and {G}omis, {J}. {F}. and {N}dour, {C}. {T}. and {M}olez, {J}ean-{F}ran{\c{c}}ois and {F}all, {F}. {B}. and {S}okhna, {C}heikh and {F}aye, {B}. and {K}ouevijdin, {E}. and {N}iane, {F}. {K}. and {C}airns, {M}. and {T}rape, {J}ean-{F}ran{\c{c}}ois and {R}ogier, {C}. and {G}aye, {O}. and {G}reenwood, {B}. {M}. and {M}illigan, {P}. {J}. {M}.}, editor = {}, language = {{ENG}}, abstract = {{B}ackground {I}t is recommended that children aged 3 months to five years of age living in areas of seasonal transmission in the sub-{S}ahel should receive {S}easonal {M}alaria {C}hemoprevention ({SMC}) with sulfadoxine-pyrimethamine plus amodiaquine ({SPAQ}) during the malaria transmission season. {T}he 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 {S}enegal 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. {M}ethods {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. {H}ealth posts were randomized to introduce {SMC} in a stepped wedge design. {SMC} with {SPAQ} was administered once per month from {S}eptember to {N}ovember, by nine health-posts in 2008, by 27 in 2009 and by 45 in 2010. {R}esults {A}fter three years, 780,000 documented courses of {SMC} had been administered. {H}igh coverage was achieved. {N}o serious adverse events attributable to the intervention were detected, despite a high level of surveillance. {C}onclusions {SMC} is being implemented in countries of the sub-{S}ahel 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 {S}enegal. {O}ur results show that {SMC} is well tolerated in children under five and in older children. {H}owever, pharmacovigilance should be maintained where {SMC} is implemented and provision for strengthening national pharmacovigilance systems should be included in plans for {SMC} implementation.}, keywords = {{SENEGAL}}, booktitle = {}, journal = {{P}los {O}ne}, volume = {11}, numero = {10}, pages = {e0162563 [15 p.]}, ISSN = {1932-6203}, year = {2016}, DOI = {10.1371/journal.pone.0162563}, URL = {https://www.documentation.ird.fr/hor/fdi:010068292}, }