Wadhwa Nitya, Basnet Sudha, Natchu Uma Chandra Mouli, Shrestha Laxman P, Bhatnagar Shinjini, Sommerfelt Halvor, Strand Tor A, Ramji Siddarth, Aggarwal K C, Chellani Harish, Govil Anuradha, Jajoo Mamta, Mathur N B, Bhatt Meenakshi, Mohta Anup, Ansari Imran, Basnet Srijana, Chapagain Ram H, Shah Ganesh P, Shrestha Binod M
Pediatric Biology Centre, Translational Health Science and Technology Institute, Faridabad, Haryana, India.
Department of Child Health, Institute of Medicine, Tribhuvan University, Kathmandu, Nepal.
BMC Pharmacol Toxicol. 2017 Jul 10;18(1):56. doi: 10.1186/s40360-017-0162-5.
An estimated 2.7 of the 5.9 million deaths in children under 5 years of age occur in the neonatal period. Severe infections contribute to almost a quarter of these deaths. Mortality due to severe infections in developing country settings is substantial despite antibiotic therapy. Effective interventions that can be added to standard therapy for severe infections are required to reduce case fatality.
METHODS/DESIGN: This is a double-blind randomized placebo-controlled parallel group superiority trial to investigate the effect of zinc administered orally as an adjunct to standard therapy to infants aged 3 days up to 2 months (59 days) hospitalized with clinical severe infection, that will be undertaken in seven hospitals in Delhi, India and Kathmandu, Nepal. In a 1:1 ratio, we will randomly assign young infants to receive 10 mg of elemental zinc or placebo orally in addition to the standard therapy for a total of 14 days. The primary outcomes hospital case fatality, which is death due to any cause and at any time after enrolment while hospitalized for the illness episode, and extended case fatality, which encompasses the period until 12 weeks after enrolment.
A previous study showed a beneficial effect of zinc in reducing the risk of treatment failure, as well as a non-significant effect on case fatality. This study was not powered to detect an effect on case fatality, which this current study is. If the results are consistent with this earlier trial, we would have provided strong evidence for recommending zinc as an adjunct to standard therapy for clinical severe infection in young infants.
Universal Trial Number: U1111-1187-6479, Clinical Trials Registry - India: CTRI/2017/02/007966 : Registered on February 27, 2017.
在590万5岁以下儿童死亡病例中，估计有270万发生在新生儿期。严重感染导致了近四分之一的此类死亡。尽管进行了抗生素治疗，但在发展中国家，严重感染导致的死亡率仍然很高。需要有效的干预措施来降低病死率，这些措施可以添加到严重感染的标准治疗中。
方法/设计：这是一项双盲随机安慰剂对照平行组优效性试验，旨在研究口服锌作为标准治疗辅助手段对3天至2个月（59天）因临床严重感染住院的婴儿的影响，该试验将在印度德里和尼泊尔加德满都的七家医院进行。我们将以1:1的比例随机分配幼儿，除标准治疗外，口服10毫克元素锌或安慰剂，共14天。主要结局指标为医院病死率，即因任何原因在入组后住院治疗疾病期间的任何时间死亡，以及延长病死率，即涵盖入组后至12周的时间段。
先前的一项研究表明，锌在降低治疗失败风险方面具有有益作用，对病死率的影响不显著。该研究没有足够的能力检测对病死率的影响，而本研究有。如果结果与早期试验一致，我们将为推荐锌作为幼儿临床严重感染标准治疗的辅助手段提供有力证据。
通用试验编号：U1111-1187-6479，印度临床试验注册中心：CTRI/2017/02/007966，于2017年2月27日注册。
