Safety and effectiveness of delivering mass drug administration for helminths through the seasonal malaria chemoprevention platform among Senegalese children: study protocol for a randomised controlled trial.
Safety and effectiveness of delivering mass drug administration for helminths through the seasonal malaria chemoprevention platform among Senegalese children: study protocol for a randomised controlled trial.
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疟疾仍然是一个主要的健康问题，特别是在撒哈拉以南非洲，那里90%以上的疾病和几乎所有的死亡都发生在儿童身上。肠道和生殖-泌尿系统寄生虫感染的共存使这一沉重负担雪上加霜。针对这些蠕虫的现有控制方案并未达到最佳效果。相反，2012年推出的一项名为季节性疟疾化学预防（SMC）的疟疾预防规划实现了75%以上的治疗覆盖率，并在儿童中预防了75-85%的无并发症和严重疟疾病例。这一令人鼓舞的发展支持有必要探索将蠕虫控制与SMC等成功平台相结合的战略。这将使控制蠕虫和疟疾与消除贫困疾病和促进风险人群健康和福祉的可持续发展目标保持一致。本研究将包括定量和定性两部分。定量部分将是一项三组、观察者盲、安慰剂对照的干预性研究，对塞内加尔东南部Saraya地区的学龄前和学龄儿童联合施用SMC和驱虫药物。将600名1-14岁的儿童随机分配到单用SMC药物、SMC药物与吡喹酮或SMC药物与阿苯达唑和吡喹酮的比例为1:1:1。主要结果将是对研究药物的主动和非主动不良反应。次要结局将是疟原虫-寄生虫合并感染的流行程度和强度，以及贫血的流行程度和平均血红蛋白浓度。该研究的定性部分将包括进行结构化访谈，以评估在随机选择的参与研究的儿童的父母/照顾者和负责提供联合服务的卫生保健工作者中联合使用抗虫药和SMC药物的可接受性、可行性、促成因素和障碍。这项研究将为加强疟疾和寄生虫联合控制的公共卫生建议提供证据。如果取得成功，该项目将进一步证明，发展中国家的卫生保健系统可以是全面的卫生管理，而不是侧重于单一疾病的垂直管理。ClinicalTrials.gov NCT05354258。于2022年4月28日注册。PACTR202204794105273。2022年4月25日注册
Malaria remains a major health problem, especially in sub-Saharan Africa where more than 90% of the disease and where nearly all deaths occur in children. Adding to this high burden is the co-existence of intestinal and genito-urinary helminth infections. Existing control programmes for these helminths are operating sub-optimally. Conversely, a malaria prevention programme, called seasonal malaria chemoprevention (SMC), introduced in 2012 has achieved more than 75% treatment coverage and prevented 75–85% cases of uncomplicated and severe malaria in children. This encouraging development supports the need to explore strategies involving the integration of helminth control with successful platforms such as SMC. This would align worm and malaria control within the Sustainable Development Goals of ending the diseases of poverty and promoting health and well-being for those at risk. This study will have quantitative and qualitative components. The quantitative component will be a three-arm, observer-blind, placebo-controlled, interventional study of co-administration of SMC and anthelminthic drugs to pre-school and school-age children in Saraya district, southeast Senegal. Six hundred children aged 1–14 years will be randomly assigned to receive either SMC drugs only, SMC drugs and praziquantel or SMC drugs and albendazole and praziquantel at a ratio of 1:1:1. The primary outcome will be solicited and unsolicited adverse reactions to the study medications. The secondary outcomes will be the prevalence and intensity of Plasmodium-helminth co-infection and the prevalence of anaemia and mean haemoglobin concentration. The qualitative component of the study will include the conduct of structured interviews to assess the acceptability, feasibility, enablers and barriers to the combined use of anthelminthic and SMC drugs among randomly selected parents/caregivers of children enrolled in the study and health care workers responsible for the delivery of the combined services. This study will provide evidence to boost the public health recommendations for combined malaria and helminth control. If successful, this project will reinforce the evidence that health care systems in developing countries can be comprehensive health management rather than focussed on vertical management of a single disease. ClinicalTrials.gov NCT05354258. Registered on 28 April 2022. PACTR202204794105273. Registered on 25 April 2022
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DOI：
10.1016/s0140-6736(20)32227-3
发表时间：
2020-12-05
期刊：
Lancet (London, England)
影响因子：
--
作者：
ACCESS-SMC Partnership
通讯作者：
ACCESS-SMC Partnership
影响因子：
3.7
作者：
Sanprasert, Vivornpun;Kerdkaew, Ruthairat;Nuchprayoon, Surang
通讯作者：
Nuchprayoon, Surang
影响因子：
3.4
作者：
Lima, Renata Monteiro;Drago Ferreira, Maria Augusta;Lanchote, Vera Lucia
通讯作者：
Lanchote, Vera Lucia
影响因子：
15.8
作者：
Bates, Imelda;McKew, Stephen;Sarkinfada, Faruk
通讯作者：
Sarkinfada, Faruk
影响因子：
15.8
作者：
Hotez PJ;Molyneux DH;Fenwick A;Ottesen E;Ehrlich Sachs S;Sachs JD
通讯作者：
Sachs JD