Clinical Research Department, London School of Hygiene and Tropical Medicine, London, UK
Clinical Research Department, London School of Hygiene and Tropical Medicine, London, UK.
BMJ Open. 2023 Jul 7;13(7):e072347. doi: 10.1136/bmjopen-2023-072347.
As malaria declines, innovative tools are required to further reduce transmission and achieve elimination. Mass drug administration (MDA) of artemisinin-based combination therapy (ACT) is capable of reducing malaria transmission where coverage of control interventions is already high, though the impact is short-lived. Combining ACT with ivermectin, an oral endectocide shown to reduce vector survival, may increase its impact, while also treating ivermectin-sensitive co-endemic diseases and minimising the potential impact of ACT resistance in this context.
MATAMAL is a cluster-randomised placebo-controlled trial. The trial is being conducted in 24 clusters on the Bijagós Archipelago, Guinea-Bissau, where the peak prevalence of () parasitaemia is approximately 15%. Clusters have been randomly allocated to receive MDA with dihydroartemisinin-piperaquine and either ivermectin or placebo. The primary objective is to determine whether the addition of ivermectin MDA is more effective than dihydroartemisinin-piperaquine MDA alone in reducing the prevalence of parasitaemia, measured during peak transmission season after 2 years of seasonal MDA. Secondary objectives include assessing prevalence after 1 year of MDA; malaria incidence monitored through active and passive surveillance; age-adjusted prevalence of serological markers indicating exposure to and anopheline mosquitoes; vector parous rates, species composition, population density and sporozoite rates; prevalence of vector pyrethroid resistance; prevalence of artemisinin resistance in using genomic markers; ivermectin's impact on co-endemic diseases; coverage estimates; and the safety of combined MDA.
The trial has been approved by the London School of Hygiene and Tropical Medicine's Ethics Committee (UK) (19156) and the Comite Nacional de Eticas de Saude (Guinea-Bissau) (084/CNES/INASA/2020). Results will be disseminated in peer-reviewed publications and in discussion with the Bissau-Guinean Ministry of Public Health and participating communities.
NCT04844905.
随着疟疾的减少，需要创新工具来进一步降低传播率并实现消除。在控制干预措施的覆盖率已经很高的情况下，大规模药物治疗（MDA）使用青蒿素为基础的联合疗法（ACT）能够降低疟疾传播，但这种影响是短暂的。将 ACT 与伊维菌素结合使用，伊维菌素是一种已被证明能降低媒介生存能力的口服驱虫药，可能会增加其效果，同时还能治疗伊维菌素敏感的共流行疾病，并最大限度地减少这种情况下 ACT 耐药的潜在影响。
MATAMAL 是一项集群随机对照试验。该试验正在几内亚比绍的比热戈斯群岛的 24 个集群中进行，这里的疟原虫峰值流行率约为 15%。集群已被随机分配接受二氢青蒿素-哌喹和伊维菌素或安慰剂的 MDA。主要目标是确定在 2 年季节性 MDA 后，在传播高峰期，伊维菌素 MDA 的添加是否比单独使用二氢青蒿素-哌喹 MDA 更能有效降低 寄生虫血症的流行率。次要目标包括评估 MDA 1 年后的流行率；通过主动和被动监测监测疟疾发病率；通过年龄调整的血清学标志物来评估表明暴露于 和按蚊的流行率；媒介产卵率、物种组成、种群密度和孢子率；媒介对拟除虫菊酯的耐药性流行率；使用基因组标记评估 中的青蒿素耐药性流行率；伊维菌素对共流行疾病的影响；覆盖率估计；以及联合 MDA 的安全性。
该试验已获得伦敦卫生与热带医学学院伦理委员会（英国）（19156）和几内亚比绍国家卫生伦理委员会（084/CNES/INASA/2020）的批准。结果将在同行评议的出版物中发表，并与比绍-几内亚公共卫生部和参与社区进行讨论。
NCT04844905。
