[TEST RECORD] Effect of single-course malaria chemoprevention on clearance of and protection from Plasmodium falciparum infection in the presence of resistance-associated genotypes in Zambia (dataset)

A two-arm, parallel, double-blind, randomised controlled trial conducted among asymptomatic children aged 3–5 years in Zambia to assess parasite clearance and protection from Plasmodium falciparum infection following antimalarial chemoprevention. Eligible children were randomly assigned to receive sulfadoxine–pyrimethamine (SP) or artesunate monotherapy. Participants were followed longitudinally with regular clinical assessments and provided blood for thick smear slides, and dried blood spots for quantitative polymerase chain reaction (qPCR) and genotype analyses. The aim of the study was to measure the chemopreventive efficacy of SP, and quantify the effect on both parasite clearance and protection from infection against parasite genotypes associated with drug resistance. Study drugs and outcome assessments were masked to participants and study staff. See the associated publication for full details on eligibility criteria, intervention regimens, follow-up procedures, and outcome definitions.

Additional Information

This work was supported by Unitaid as part of a larger implementation project managed by Population Services International (Ref: 101150IC awarded to RG). The funder plays no part in the design or conduct of this study. The study has undergone full external peer review before the grant was awarded and has been registered on clinicaltrials.gov (NCT06173206) on December 15, 2023.

Keywords

Chemoprevention; Intermittent preventive treatment; Antimalarial resistance; Sulphadoxine-Pyrimethamine; Sulphadoxine-Pyrimethamine plus Amodiaquine; Clinical trial