Protocol for a cluster randomised placebo-controlled trial of adjunctive ivermectin mass drug administration for malaria control on the Bijagós Archipelago of Guinea-Bissau: the MATAMAL trial.

Protocol for a cluster randomised placebo-controlled trial of adjunctive ivermectin mass drug administration for malaria control on the Bijagós Archipelago of Guinea-Bissau: the MATAMAL trial.
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辅助性伊维菌素大量药物给药的簇随机安慰剂对照试验的方案,该试验是对几内亚 - 比索的Bijagós群岛控制的疟疾控制:MATAMAL试验。

DOI:
10.1136/bmjopen-2023-072347
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发表时间:
2023-07-07
期刊:
影响因子:
2.9
通讯作者:
Last, Anna R.
Last, Anna R.
中科院分区:
医学3区
文献类型:
--
作者:
Hutchins, Harry;Bradley, John;Pretorius, Elizabeth;da Silva, Eunice Teixeira;Vasileva, Hristina;Jones, Robert T.;Ndiath, Mamadou Ousmane;Soumare, Harouna Dit Massire;Mabey, David;Nante, Ernesto Jose;Martins, Cesario;Logan, James G.;Slater, Hannah;Drakeley, Chris;D'Alessandro, Umberto;Rodrigues, Amabelia;Last, Anna R.

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随着疟疾的减少,需要创新的工具来进一步减少传播和实现消除疟疾。在控制干预措施覆盖率已经很高的地区,大规模给药青蒿素类联合疗法能够减少疟疾传播,尽管这种影响是短暂的。联合青蒿素与伊维菌素(一种口服灭尾剂,可减少病媒存活)可能会增加其效果,同时还可治疗对伊维菌素敏感的共流行疾病,并在这种情况下将青蒿素耐药性的潜在影响降至最低。MATAMAL是一项集群随机安慰剂对照试验。该试验正在几内亚比绍Bijagós群岛的24个聚集性病例中进行,那里恶性疟原虫(Pf)寄生虫病的最高流行率约为15%。随机分组接受丙二氢青蒿素-哌喹和伊维菌素或安慰剂的治疗。主要目的是确定添加伊维菌素丙二醛是否比单独使用双氢青蒿素-哌喹丙二醛更有效地降低恶性疟原虫寄生虫病的患病率,这是在使用2年季节性丙二醛后的传播高峰期测量的。次要目标包括评估MDA 1年后的患病率;通过主动和被动监测监测疟疾发病率;显示暴露于恶性疟原虫和按蚊的血清学标志物的年龄调整患病率;病媒产率、种类组成、种群密度和孢子率;媒介拟除虫菊酯耐药性流行情况;利用基因组标记分析恶性疟原虫对青蒿素的耐药性;伊维菌素对共地方病的影响;报道估计;以及联合丙二醛的安全性。该试验已获得伦敦卫生和热带医学学院伦理委员会(英国)(1956年)和沙特国家医学委员会(几内亚比绍)(084/CNES/INASA/2020)的批准。研究结果将在同行评议的出版物中传播,并与几内亚比绍公共卫生部和参与社区进行讨论。NCT04844905。
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 Plasmodium falciparum (Pf) 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 P. falciparum 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 P. falciparum and anopheline mosquitoes; vector parous rates, species composition, population density and sporozoite rates; prevalence of vector pyrethroid resistance; prevalence of artemisinin resistance in P. falciparum 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.
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