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Seasonal Malaria Chemoprevention Therapy in Children Up To 9 Years of Age: Protocol for a Cluster-Randomized Trial Study

Version 3 2024-06-19, 23:35
Version 2 2024-06-03, 02:52
Version 1 2024-02-06, 04:15
journal contribution
posted on 2024-06-03, 02:52 authored by Mahamoudou Toure, Jeffrey G Shaffer, Daouda Sanogo, Soumba Keita, Moussa Keita, Fousseyni Kane, Bourama Traore, Djeneba Dabitao, Aissata Kone, Cheick Oumar Doumbia, Joseph Keating, Joshua Yukich, Helle H Hansson, Alyssa E Barry, Mahamadou Diakité, Michael Alifrangis, Seydou Doumbia
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 3 months old to younger than 5 years. Since 2016, the Malian National Malaria Control Program has deployed SMC countrywide during its high malaria transmission season at a rate of 4 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; therefore, 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 effectively prevents malaria in children aged 5 years or older. Objective The primary goal of the study is to compare 2 SMC regimens (SP-AQ and dihydroartemisinin-piperaquine [DHA-PQ]) in preventing uncomplicated Plasmodium falciparum malaria in children 3 months to 9 years old. Secondly, we will assess the possible use of DHA-PQ as an alternative SMC drug in areas where resistance to SP or AQ may increase following intensive use. Methods The study design is a 3-arm cluster-randomized design comparing the SP-AQ and DHA-PQ arms in 2 age groups (younger than 5 years and 5-9 years) and a control group for children aged 5-9 years. Standard SMC (SP-AQ) for children younger than 5 years was provided to the control arm, while SMC with SP-AQ was delivered to children aged 3 months to 9 years (arm 2), and SMC with DHA-PQ will be implemented in study arm 3 for children up to 9 years of age. The study was performed in Mali’s Koulikoro District, a rural area in southwest Mali with historically high malaria transmission rates. The study’s primary outcome is P falciparum incidence for 2 SMC regimens in children up to 9 years of age. Should DHA-PQ provide an acceptable alternative to SP-AQ, a plausible second-line prevention option would be available 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 4556 children 3 months old to younger than 5 years were enrolled. Data collection ended in spring 2023, and the findings are expected to be published later in early 2024. 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. Trial Registration ClinicalTrials.gov NCT04149106, https://clinicaltrials.gov/ct2/show/NCT04149106 International Registered Report Identifier (IRRID) DERR1-10.2196/51660

History

Journal

JMIR Research Protocols

Volume

13

Article number

e51660

Pagination

1-9

Location

Toronto, Canada

ISSN

1929-0748

eISSN

1929-0748

Language

eng

Publication classification

C1 Refereed article in a scholarly journal

Publisher

JMIR Publications