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临床试验/NCT02225769
NCT02225769已完成不适用

Electronic Algorithms Based on Host Biomarkers Point of Care Tests to Decide on Admission and Antibiotic Prescription in Tanzanian Febrile Children

Swiss Tropical & Public Health Institute1 个研究点 分布在 1 个国家目标入组 3,192 人开始时间: 2014年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
3,192
试验地点
1
主要终点
Proportion of clinical failure by day 7 compared among the 3 study arms.

研究概览

简要总结

Health professionals in developing countries have limited ability to identify children at risk of dying and those in need of antibiotics. The main reasons are limited clinical skills and time, unavailability of diagnostic tests (laboratory or x-ray) and non-adherence to practice guidelines. Child mortality is therefore higher than it should be. Etiological diagnostic tests (detecting microorganisms) may not always help since the distinction between infection and disease and between mild or severe disease is not straightforward. Overprescription of antibiotics is therefore widespread and leads to the development of drug resistance. To address these challenges, decision charts for the management of febrile illness will be developed and include i) few clinical parameters simple to assess, and ii) POCTs results based on specific host markers that can discriminate between mild and severe disease, pneumonia and upper respiratory tract infections, and unspecific fevers of bacterial and of viral origin. This algorithm combining clinical and bedside laboratory tests will be built on an electronic support (android tablet). The first objective of the study is to assess the safety of new electronic decision trees that integrate simple clinical assessment and POCTs results (oxygen saturation and a combination of specific biomarkers of inflammation) as a triage tool to decide on admitting febrile children; the second objective is to assess the usefulness and safety of new electronic decision trees that integrate simple clinical assessment and POCT results (a combination of specific biomarkers of inflammation) as decision-making tool to prescribe antibiotics to non-severe febrile children. The development of such a tool will decrease mortality due to delayed admission, At the same time, it will decrease irrational use of antibiotics, and hence drug pressure and emergence of drug resistance, which represents one of the most important public health threat our world is facing today. This project has the potential of huge applicability since it is specifically designed for end-users with limited medical skills and low resources, as it is the case in most areas of developing countries.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
2 Months 至 59 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Age ≥2 months and <60 months of age
  • Written informed consent from the child's parent or caregiver
  • Axillary temperature ≥37.5°C and/or tympanic temperature ≥38.0°C
  • History of fever for ≤7 days
  • First consultation for the current illness
  • Live in the catchment area of the health facility

排除标准

  • Age 60 months or greater
  • Age less than 2 months
  • Weight less than 2.5kg
  • Chief health problem is an injury, trauma or acute poisoning

结局指标

主要结局

Proportion of clinical failure by day 7 compared among the 3 study arms.

时间窗: 10 months

This outcome measure is used to compare the clinical outcome of febrile children 2-59 months of age managed using e-POCT (intervention arm), ALMANACH (reference control arm) and routine practice (routine control arm).

次要结局

  • Proportions of children prescribed an antibiotic and/or antimalarial treatment at day 0 and by day 7 compared among the 3 study arms.(10 months)
  • Proportions of secondary hospitalization and death by day 30 compared among the 3 study arms.(10 months)
  • Proportions of children with hypoxemia, stratified by diagnostic classification (e-POCT arm)(10 months)
  • Proportion of primarily admitted children compared among the 3 study arms.(10 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Valérie D'Acremont

Group leader

Swiss Tropical & Public Health Institute

研究点 (1)

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