Chemoprevention Efficacy Study in Burkina Faso

Malaria Consortium

Status and phase

Active, not recruiting

Phase 4

Conditions

Malaria

Treatments

Drug: Sulfadoxine pyrimethamine

Drug: Amodiaquine

Study type

Interventional

Funder types

Other

Identifiers

NCT05478954

SMCBFPHASE1

Details and patient eligibility

About

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.

Full 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:

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
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)

Enrollment

800 patients

Sex

All

Ages

3 to 59 months old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Children between 3-59 months
Being resident in the project area
Afebrile with no other malaria associated symptoms in the past 48 hours or at time of recruitment
Consent to participate in the study obtained
Can comply with 3 day DOT of standard SPAQ regimen (day 0-2)
Willingness and ability of the childs guardians to comply with the study protocol for the duration of the study including all dry blood spot and slide collections

Exclusion criteria

Symptoms of malaria (tympanic fever ≥ 37.5 °C or history of fever in past 48 hours)
Known allergy to medicine provided
Receiving a sulfa-based medication for treatment or prophylaxis, including co-trimoxazole (trimethoprim-sulfamethoxazole).
Individuals receiving azithromycin due to the antimalarial activity of azithromycin.
Severe malnutrition according to WHO guidelines
Recruited in cross sectional surveys or any other SMC studies.