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临床试验/NCT06697041
NCT06697041已完成不适用

Clinical and Laboratory Factors for the Progression of Severe Dengue Among Hospitalized Patients During an Upsurge

International Centre for Diarrhoeal Disease Research, Bangladesh1 个研究点 分布在 1 个国家目标入组 324 人开始时间: 2024年1月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
324
试验地点
1
主要终点
Laboratory infection markers and immune parameters

研究概览

简要总结

Hypothesis (if any): Not applicable Objectives: To identify factors for progression to severe Dengue in hospitalized patients.

Methods: Prospective Observational study

详细描述

Global perspective:

Mosquito-borne dengue is a global public health issue in the tropics and subtropics. Dengue is endemic in over 100 countries, according to WHO. Around 40% of the world's population-3.6 billion-lives in dengue-endemic areas. Dengue infects 400 million people, sickens 100 million, and kills 21,000 each year. In studies of acute febrile illness in US visitors returning from South-central and Southeast Asia, South America, Mexico, and the Caribbean, dengue is the main cause due to increased international travel and the popularity of dengue-endemic destinations. Thus, dengue-related US hospitalizations are rising. Prevention methods, such as early detection and prompt clinical therapy, can lower case fatality rates from 10% to <1%.

National perspective:

Dengue has been hyperendemic in Bangladesh since 2000. The current dengue spike is exceptional in its seasonality and an early fast increase compared to past years, which began in late June. According to WHO, this year's case fatality rate is 0.47%, higher than usual. However, Bangladeshi clinical spectrum, serotype predominance, novel and modified serotypes (DEVN-5), and immunological responses need more research. However, future dengue prevention and treatment techniques require serotype-specific clinical and laboratory indicators and immune reactivity in distinct spectrums.

This research is conducted in hospitals to identify the burden of severe dengue and its link to dengue fever in our country. Dengue fever is now managed supportively without antiviral medication. The cause of severe and potentially deadly dengue is unknown. Prior DENV exposure, co-morbidity, and genetic predisposition may increase the risk of severe dengue sickness. The study results will help us understand and solve the problem. The aim is to assess the clinical and laboratory parameters related to severe Dengue and the transition from non-severe to severe Dengue in hospitalized Bangladeshis.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
1 Year 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Dengue fever with warning signs with Ns1 positive and or IgM positive
  • Informed written consent or assent.

排除标准

  • Severe dengue during screening or denied consenting

结局指标

主要结局

Laboratory infection markers and immune parameters

时间窗: 01/01/2024 to 30/06/2025

Laboratory biomarkers, immune factor, serotyping

Host factors & comorbidities

时间窗: January 01- June 30; 2025

Association with age, sex, co-morbid condition, care seeking behaviours

Sociodemographic factors

时间窗: On admission

Resident, occupation, monthly income, living condition, health-seeking behaviors

Clinical progression parameters during hospitalization

时间窗: January 01, 2024 to December 31, 2024

Clinical sign symptoms during admission and then differences at final outcome, such as on discharge or in death.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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