NCT05650502|CompletedFDA Drug
Impact of Seasonal Malaria Chemoprevention on Immunity Against Malaria Among Children in Northern Benin
ISAMIMA
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ISAMIMA
Sponsor study identifier
observational
440
1 country
1
Study Start
June 1, 2021
Actual (reported)Primary Completion
August 30, 2021
Actual (reported)Study Completion
May 30, 2022
Actual (reported)This study aims to evaluate the effects of SMC (Seasonal malaria chemoprevention) with Sulfadoxine-Pyrimethamine (SP) and Amodiaquine (AQ) on the evolution of anti-malarial immunity of children and their susceptibility to malarial infection. This is a cross-sectional study on children aged 6 to 59 months with/without SMC in two villages in northern Benin. Sociodemographic and clinical data as well as repeated blood samples will be collected from 440 children (before, during and after treatment). Samples will be analyzed using a Luminex assay to investigate antibody responses to MSP (merozoite surface protein) , Glurp (Glutamate-Rich Protein) and a panel of PfEMP1. qPCR (quantitative polymerase chain reaction) will be used to detect the prevalence of malaria at this period and parasites infecting children will be characterize during the follow up.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 30, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 1, 2021
Actual (reported)August 30, 2021
Actual (reported)May 30, 2022
Actual (reported)December 4, 2022
Actual (reported)December 14, 2022
Actual (reported)Efficiency of Seasonal malaria chemoprevention
Malaria prevalence during the intervention
January 2023
Impact of Seasonal malaria chemoprevention
June 2023
This group included children from 6 to 59 months living in Cobly and receiving the SMC treatment. The treatment is administered for three consecutives days for 4 months (from july to october). For children under 12 months: one dose of SP 250/12.5mg on day 1 AQ 75mg once daily for 3 days For children from 12 to 59 months: one dose of SP 500/25mg on day 1 AQ 150 mg once daily for 3 days A monthly visit was planned for monitoring during the follow up. Sample was collected in jun, september, january and April.
This group included children from 6 to 59 months living inTchaourou and who did not receiving the SMC treatment. A monthly visit was planned for monitoring during the follow up. Sample was collected in jun, september, january and April.
Investigate the impact of saisonal malaria chimoprevention on children anti PfEMP1 construction and maintenance and their succeptibility to malaria infection
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Children who meet the inclusion and exclusion criteria, living in the communes of Cobly and Tchaourou located in northern Benin, whether or not they have received Saisonal malaria chimotreatment, will be recruited.
Azizath MOUSSILIOU
Parakou, Benin
Nicaise TIUKUE NDAM, Professor
Institut régional de développement IRD (UMR261)
Adrian LUTY, Professor
Institut régional de développement IRD (UMR261)
440 participants (actual enrollment reported by the registry).
First Submitted
December 4, 2022
First Posted
December 14, 2022
Study Start
June 1, 2021
Actual (reported)COVID-19 Post-Vaccination Observation
Contact the study team to confirm eligibility.
Primary Completion
August 30, 2021
Actual (reported)Study Completion
May 30, 2022
Actual (reported)Last Updated
December 28, 2022
Record last verified: 2022-12
Protocol and the informed consent will be shared with other researchers
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Source: ClinicalTrials.gov.
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