Accepted for/Published in: JMIR Research Protocols
Date Submitted: Aug 7, 2023
Date Accepted: Oct 26, 2023
Seasonal malaria chemoprevention therapy in children aged under 10 years: A cluster-randomized trial study protocol
ABSTRACT
Background:
Seasonal malaria chemoprevention (SMC) is recommended by the World Health Organization for the sub-Sahel region in sub-Saharan Africa for preventing malaria in children between 3 months and 5 years old. Since 2016, the Malian National Malaria Control Program has deployed SMC countrywide during its high malaria transmission season at a rate of four monthly cycles annually. The standard SMC regimen includes sulfadoxine-pyrimethamine (SP) plus amodiaquine (AQ). Resistance against SP is suspected to be rising across West Africa, and thus assessing the effectiveness of an alternative antimalarial drug for SMC is needed to provide a second-line regimen when it is ultimately needed. It is not well-understood whether SMC is effective in preventing malaria in children five years of age or older.
Objective:
The primary goal of the study is to determine compare two SMC regimens (SP-AQ and dihydroartemisinin-piperaquine [DHA-PQ]) in preventing uncomplicated P. falciparum malaria in children between 3 months and 9 years old.
Methods:
The study design is a three-arm cluster-randomized design comparing SP-AQ and DHA-PQ arms in two age groups (under 5 years of age and 5 to 9 years of age), and a control group for children aged 5 to 9 years. The study was performed in Mali’s Koulikouro District, a rural area situated in southwest Mali with historically high rates of malaria transmission. The primary outcome for the study is P. falciparum incidence for two SMC regimens in children under 10 years of age. Should DHA-PQ provide an acceptable alternative to SP-AQ, a plausible alternative to conventional SMC would be available as a second line prevention option in the event of SP resistance or drug supply shortages. A significant byproduct of this effort included bolstering district health information systems for rapid identification of severe malaria cases.
Results:
The study began on July 1, 2019. Through November 2022, a total of 4,556 children between 3 months and 5 years old were enrolled.
Conclusions:
Routine evaluation of antimalarial drugs is needed to establish appropriate SMC age targets. The study goals here may impact public health policy and provide alternative therapies in the event of drug shortages or resistance. Clinical Trial: ClinicalTrials.gov NCT04149106, https://clinicaltrials.gov/ct2/show/NCT04149106
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