NCT05478954

Chemoprevention Efficacy Study in Burkina Faso

Seasonal Malaria Chemoprevention in Burkina Faso : Chemoprevention Efficacy Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 800 (actual)
• Sponsor: Malaria Consortium · Academic / Other
• Sex: All
• Age: 3 Months – 59 Months
• Healthy volunteers: Accepted

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.

Detailed 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)

Conditions

• Malaria

Interventions

Type	Name	Description
DRUG	Sulfadoxine pyrimethamine	Sulphadoxine is a slowly eliminated sulphonamide. It is used in a fixed dose combination of 20 parts sulphadoxine with 1 part pyrimethamine given orally or intramuscularly. The medicine is no longer recommended for the treatment of malaria. However, it is being used for Intermittent Preventive Treatment during pregnancy (IPTp) and as a co-packaged combination with amodiaquine for seasonal malaria chemoprevention. Sulphadoxine is readily absorbed from the GIT. It is widely distributed in body tissues and fluids and crosses the placenta into foetal circulation. It is also readily detectable in breast milk. It is excreted predominantly as the unchanged drug.
DRUG	Amodiaquine	Amodiaquine is a Mannich base 4 amino-quinoline that interferes with parasite haem detoxification. It is more effective than chloroquine in both chloroquine sensitive and resistant P. falciparum infections. However, there is cross-resistance between chloroquine and amodiaquine. It is readily absorbed in the GIT and rapidly converted in the liver to the active metabolite, desethylamodiaquine. Desethylamodiaquine is responsible for all the antimalarial effect. Adverse effect of amodiaquine includes abdominal discomfort and vomiting weakness and when used for prophylaxis it causes agranulocytosis. Amodiaquine is recommended as a partner drug in artemisinin based combination therapy.

Timeline

• Start date: 2022-07-15
• Primary completion: 2022-10-01
• Completion: 2023-12-01
• First posted: 2022-07-28
• Last updated: 2023-11-01

Locations

1 site across 1 country: Burkina Faso