Seasonal Malaria Chemoprevention in Burkina Faso : Chemoprevention Efficacy Study
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Chemoprevention failure as defined by qPCR positive parasites or malaria slide positive parasites
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Sulfadoxine-Pyrimethamine + Amodiaquine (SPAQ)
Children aged 3-59 months will receive SPAQ during the study period.
干预措施: Sulfadoxine pyrimethamine (Drug)
Sulfadoxine-Pyrimethamine + Amodiaquine (SPAQ)
Children aged 3-59 months will receive SPAQ during the study period.
干预措施: Amodiaquine (Drug)
结局指标
主要结局
Chemoprevention failure as defined by qPCR positive parasites or malaria slide positive parasites
时间窗: One month
Malaria slides and dry blood spots (DBS) taken at days 0,7,14, 21, 28 of a one month drug administration cycle will be analysed to detect parasitemia in children treated with SPAQ. Chemoprevention failure has occured if a malaria slide is positive for parasites 7 days or more after drug administration or if a qPCR detects low level parasitemia at the end of the administration cycle (one month).
Drug concentrations of Sulfadoxine-pyrimethamine and amodiaquine among chemoprevention failures (as defined in outcome 1)
时间窗: One month
Drug concentrations of SPAQ will be analyzed on all samples (taken at days 7,14,21,28 throughout the one month cycle) in order to be linked to chemoprevention failures as defined in outcome 1.
Prevalence of antimalarial resistance markers among chemoprevention failures (as defined in outcome 1)
时间窗: One month
All Dried blood spots (DBS) will be analysed for malaria mutation genotypes (dhfr, dhps, Pfcrt, pfmdr1) on baseline and endline and additionally throughout the cycle if a chemoprevention failure (as defined in outcome 1) has occured.
次要结局
- Prevalence over time of parasites with dhfr/dhps/pfcrt/pfmdr1 mutations in symptomatic children with a positive diagnostic test residing in districts where SMC is implemented(Five months)