Chemoprevention Efficacy Study in Burkina Faso

Malaria Clinical Trial

Official title: Seasonal Malaria Chemoprevention in Burkina Faso : Chemoprevention Efficacy Study

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

This cohort study aims to evaluate the effects of a clinical intervention on relevant outcomes whilst collecting information on implementation.

The study uses pragmatic implementation research with the objective of contributing to the development of practical recommendations for health policy, practice and potential scale up. It is designed as an implementation study to determine effectiveness and protective efficacy to gather evidence of the potential impact on health outcomes. Five monthly cycles of SMC will be implemented between July and October 2022 in one district, Nanoro, in Centre Ouest region.

The study will comprise the following two components:

1. A prospective protective efficacy cohort study to determine if SPAQ provides 28 days of protection from infection and whether drug concentrations and/or resistance influence the duration of protection

2. A resistance markers study in children 3-59 months in the two research districts plus the two standard intervention districts to measure changes in resistance marker prevalence over time (pre and post within the same year and between years) ;

Related Conditions & MeSH terms

• Malaria

• NCT number: NCT05478954
• Study type: Interventional
• Source: Malaria Consortium
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: July 15, 2022
• Completion date: December 1, 2023