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A Comparison of Diagnostic Approaches for Malaria and Pneumonia

2016年8月30日 更新者:University of Nottingham

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

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.

研究概览

地位

未知

条件

详细说明

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.

研究类型

观察性的

注册 (实际的)

1000

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Edo State
      • Benin City、Edo State、尼日利亚
        • Health Services Department, University of Benin

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

3年 至 3个月 (孩子)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

The study population are children aged 2 months to four years old who are residents in the catchment local government area of study primary healthcare centres in Benin City, Edo State, Nigeria.

描述

Inclusion Criteria:

  • 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.

Exclusion Criteria:

None

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:队列
  • 时间观点:预期

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Malaria confirmed by microscopy (yes/no)
大体时间: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
Participants will be assessed within an average period of 24 hours of presenting to study primary healthcare centres
Pneumonia confirmed by chest x-ray (yes/no)
大体时间: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
Participants will be assessed within an average period of 48 hours of presenting to study primary healthcare centres

次要结果测量

结果测量
措施说明
大体时间
Hospitalisation (yes/no)
大体时间:Within 30 days of first consultation
This will be assessed for all study participants with either a malaria or pneumonia diagnosis as part of an epidemiological study
Within 30 days of first consultation
Death (yes/no)
大体时间:Within 30 days of first consultation
This will be assessed for all study participants with either a malaria or pneumonia diagnosis as part of an epidemiological study
Within 30 days of first consultation

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Kelly O Elimian, MSc、University of Nottingham & University of Benin
  • 研究主任:Puja R Myles, PhD、University of Nottingham
  • 研究主任:Catherine Pritchard, PhD、University of Nottingham
  • 研究主任:Ayebo Sadoh, PhD、University of Benin

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年8月1日

初级完成 (预期的)

2017年7月1日

研究完成 (预期的)

2017年7月1日

研究注册日期

首次提交

2015年6月22日

首先提交符合 QC 标准的

2015年6月25日

首次发布 (估计)

2015年6月26日

研究记录更新

最后更新发布 (估计)

2016年8月31日

上次提交的符合 QC 标准的更新

2016年8月30日

最后验证

2016年8月1日

更多信息

与本研究相关的术语

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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