Randomized Control Trial of Nitazoxanide for the Treatment of Cryptosporidium Infection in Malnourished Children in Bangladesh

项目摘要 隐孢子虫病是全球儿童发病率和死亡率的主要贡献者， 造成20多万两岁以下儿童死亡，700多万儿童患病。然而， 我们有有限的治疗方法，也没有用于幼儿的疫苗。我们之前的工作是 孟加拉国已经证明，城市贫民窟队列中近80%的儿童是 感染隐孢子虫。到两岁时，这种感染，即使没有腹泻，也是 与长期增长停滞不前密切相关。硝唑尼特是FDA批准的唯一 治疗隐孢子虫腹泻病的药物。然而，这种药物已经限制了 由于缺乏大规模、不偏不倚的严格试验来证明其在 一岁以下的儿童，并在这一人群中建立其安全性。此外，人们对此知之甚少。 关于该药如何治疗非腹泻感染和缓解隐孢子虫对人的影响 儿童成长。 在这里，我们提出了一项旨在治疗儿童的双盲、随机、安慰剂对照试验。 6-12个月龄，患有隐孢子虫腹泻和非腹泻感染。这项研究将 评估对这两种情况的治疗效果，并将评估是否治疗 治疗后6个月可改善儿童生长发育。 这项提议充分利用了约翰·霍普金斯大学和 国际腹泻病研究中心，孟加拉国。这一提议是创新的， 因为这将是第一个旨在治疗非腹泻的随机对照试验 隐孢子虫感染，并将评估对生长的影响。这项研究的发现将 告知治疗努力，以帮助保护幼儿免受这种毁灭性传染病的侵袭。

Project Summary Cryptosporidiosis is a leading contributor to child morbidity and mortality worldwide, responsible for over 200,000 deaths in children under two, and morbidity in over 7 million children. However, we have limited treatment and no vaccine for use in young children. Our prior work in Bangladesh has demonstrated that almost 80% of children in an urban slum cohort were infected with Cryptosporidium spp. by age two and that infection, even without diarrhea, was significantly associated with long-term growth faltering. Nitazoxanide is the only FDA-approved drug for treatment of Cryptosporidium diarrheal disease. However, the drug has limited widespread due to lack of large-scale, unbiased rigorous trials demonstrating its efficacy in children under one and establishing its safety in this population. Furthermore, little is known about how the drug could treat non-diarrheal infection and alleviate Cryptosporidium’s effect on child growth. Here we propose a double-blind, randomized, placebo-controlled trial aimed at treating children ages 6-12 months with Cryptosporidium-diarrheal and non-diarrheal infection. The study will evaluate the efficacy of treatment for both conditions and will also evaluate whether treatment can improve growth in children for 6 months post-treatment. This proposal leverages a longstanding collaboration between Johns Hopkins University and the International Centre for Diarrhoeal Disease, Research, Bangladesh. This proposal is innovative, as it will be the first randomized controlled trial aimed at treatment of non-diarrheal Cryptosporidium infection and will evaluate impact on growth. The findings from this study will inform treatment efforts aid to protect young children from this devastating infectious disease.