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临床试验/NCT02482116
NCT02482116Unknown不适用

Malaria and Pneumonia in Children Under the Age of Five Years Old Presenting to Primary Healthcare Centres in Benin City, Nigeria: a Comparison of Early Diagnostic Approaches

University of Nottingham1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2015年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,000
试验地点
1
主要终点
Malaria confirmed by microscopy (yes/no)

研究概览

简要总结

This research investigates the diagnostic accuracy of various diagnostic approaches for malaria and pneumonia in under-five children presenting to primary healthcare centres in Benin City, Nigeria.

详细描述

Of the preventable and treatable diseases, both malaria and pneumonia are significant contributors to under-five mortality in Nigeria. To reduce the burden of these diseases, the Integrated Management of Childhood Illness (IMCI) guidelines were developed by the World Health Organisation (WHO) to be used at first point of contact (e.g., primary healthcare centres) with children under the age of five years old. Preliminary literature review suggests that although interventions based on numerous diagnostic approaches have been trialed, burden from malaria and pneumonia remains unacceptably high in Nigeria, suggesting limited effectiveness of existing approaches. Therefore, this study aims to compare the accuracy of different early diagnostic approaches used in the community(for e.g. the WHO Integrated Management of Childhood Illness (IMCI) guidelines versus the gold standard diagnostic tests comprising microscopy in malaria and chest radiography in pneumonia) in children under the age of five years presenting with suspected malaria and pneumonia to primary healthcare centres in Benin City, Edo State of Nigeria.

The research will compare the accuracy of these various diagnostic approaches using measures such as sensitivity, specificity, positive predictive value, negative predictive value, and area under the receiver operating characteristic curve. The research will also assess patient outcomes like complications, hospitalisation and death following a diagnosis of either pneumonia or malaria in all study participants as well as costs associated with malaria and pneumonia.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
2 Months 至 4 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Suspected malaria (symptoms reported by caregiver that are consistent with malaria: high temperature, chills and no other probable diagnosis)
  • Suspected pneumonia (fever, cough, shortness of breath/difficulty in breathing, with or without chills and no other probable diagnosis)
  • Willingness of caregiver to provide written or verbal consent in the presence of a witness.

排除标准

  • 未提供

结局指标

主要结局

Malaria confirmed by microscopy (yes/no)

时间窗: Participants will be assessed within an average period of 24 hours of presenting to study primary healthcare centres

This is the gold standard diagnosis for malaria and will be used to assess the accuracy of other diagnostic approaches

Pneumonia confirmed by chest x-ray (yes/no)

时间窗: Participants will be assessed within an average period of 48 hours of presenting to study primary healthcare centres

This is the gold standard test for pneumonia and will be used to assess the accuracy of other diagnostic approaches

次要结局

  • Hospitalisation (yes/no)(Within 30 days of first consultation)
  • Death (yes/no)(Within 30 days of first consultation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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