drugset / Trial / NCT05478954

Chemoprevention Efficacy Study in Burkina Faso

NCT05478954

Phase 4 Unknown 800 enrolled Malaria Consortium
NaSingle-groupOpen-labelPrevention

Summary

The aim of this study is to determine whether Seasonal Malaria Chemoprevention (SMC) remains effective in the health district of Nanoro in the Centre-Ouest region or Boussé in the Plateau Central region. It also aims to assess the protective efficacy of the antimalarial drugs used in SMC in the target population and to investigate levels of parasite resistance in the study districts. According to the results, this trial should provide the evidence needed to change the drugs used in SMC. A Type II hybrid effectiveness-implementation study design will be used to evaluate the effects of a clinical intervention on relevant outcomes whilst collecting information on implementation. It is designed to determine feasibility and effectiveness of an innovative intervention, as well as the protective efficacy of the antimalarial drugs used. The study consists of two components: 1) Conducting a prospective cohort study to determine the protective efficacy of the drug combination Sulfadoxine-Pyrimethamine and Amodiaquine (SPAQ) (if SPAQ provides 28 days of protection from infection) and whether drug concentrations and/or resistance influence the duration of protection; 2) Conducting a resistance markers study in symptomatic patients in the research district.

Timeline

Start
2022-07-15
Primary completion
2022-10-01
Completion
2023-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Sulfadoxine-pyrimethamine Small molecule Oral
Subject amodiaquine Other / unclassified

Indications