Department of Infection Biology, London School of Hygiene & Tropical Medicine, London, UK.
Groupe de Recherche Action en Santé, Ouagadougou, Burkina Faso.
BMJ Open. 2024 Mar 12;14(3):e081682. doi: 10.1136/bmjopen-2023-081682.
Seasonal malaria chemoprevention (SMC) involves repeated administrations of sulfadoxine-pyrimethamine plus amodiaquine to children below the age of 5 years during the peak transmission season in areas of seasonal malaria transmission. While highly impactful in reducing malaria burden in controlled research settings, the impact of SMC on infection prevalence is moderate in real-life settings. It remains unclear what drives this efficacy decay. Recently, the WHO widened the scope for SMC to target all vulnerable populations. The Ministry of Health (MoH) in Burkina Faso is considering extending SMC to children below 10 years old. We aim to assess the impact of SMC on clinical incidence and parasite prevalence and quantify the human infectious reservoir for malaria in this population.
We will perform a cluster randomised trial in Saponé Health District, Burkina Faso, with three study arms comprising 62 clusters of three compounds: arm 1 (control): SMC in under 5-year-old children, implemented by the MoH without directly observed treatment (DOT) for the full course of SMC; arm 2 (intervention): SMC in under 5-year-old children, with DOT for the full course of SMC; arm 3 (intervention): SMC in under 10-year-old children, with DOT for the full course of SMC. The primary endpoint is parasite prevalence at the end of the malaria transmission season. Secondary endpoints include the impact of SMC on clinical incidence. Factors affecting SMC uptake, treatment adherence, drug concentrations, parasite resistance markers and transmission of parasites will be determined.
The London School of Hygiene & Tropical Medicine's Ethics Committee (29193) and the Burkina Faso National Medical Ethics Committee (Deliberation No 2023-05-104) approved this study. The findings will be presented to the community; disease occurrence data and study outcomes will also be shared with the Burkina Faso MoH. Findings will be published irrespective of their results.
NCT05878366.
季节性疟疾化学预防（SMC）涉及在季节性疟疾传播地区的高峰传播季节，反复给 5 岁以下儿童服用磺胺多辛-乙胺嘧啶加阿莫地喹。虽然在控制研究环境中对降低疟疾负担具有高度影响力，但 SMC 对感染率的影响在现实生活环境中是中等的。目前尚不清楚是什么导致了这种疗效衰减。最近，世界卫生组织扩大了 SMC 的范围，将所有弱势群体作为目标。布基纳法索卫生部正在考虑将 SMC 扩大到 10 岁以下的儿童。我们旨在评估 SMC 对临床发病率和寄生虫流行率的影响，并量化该人群中疟疾的人类感染库。
我们将在布基纳法索萨蓬健康区进行一项集群随机试验，共有三个研究臂，包括 62 个由三个化合物组成的集群：臂 1（对照组）：由卫生部在 5 岁以下儿童中实施 SMC，不进行全疗程直接观察治疗（DOT）；臂 2（干预组）：在 5 岁以下儿童中实施 SMC，进行全疗程 DOT；臂 3（干预组）：在 10 岁以下儿童中实施 SMC，进行全疗程 DOT。主要终点是疟疾传播季节结束时的寄生虫流行率。次要终点包括 SMC 对临床发病率的影响。将确定影响 SMC 吸收率、治疗依从性、药物浓度、寄生虫耐药标志物和寄生虫传播的因素。
伦敦卫生与热带医学学院伦理委员会（29193）和布基纳法索国家医学伦理委员会（审议号 2023-05-104）批准了这项研究。研究结果将向社区报告；疾病发生数据和研究结果也将与布基纳法索卫生部共享。无论结果如何，都将发表研究结果。
NCT05878366。
