- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02482116
A Comparison of Diagnostic Approaches for Malaria and Pneumonia
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
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Edo State
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Benin City, Edo State, 나이지리아
- Health Services Department, University of Benin
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 유망한
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Malaria confirmed by microscopy (yes/no)
기간: Participants will be assessed within an average period of 24 hours of presenting to study primary healthcare centres
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This is the gold standard diagnosis for malaria and will be used to assess the accuracy of other diagnostic approaches
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Participants will be assessed within an average period of 24 hours of presenting to study primary healthcare centres
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Pneumonia confirmed by chest x-ray (yes/no)
기간: Participants will be assessed within an average period of 48 hours of presenting to study primary healthcare centres
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This is the gold standard test for pneumonia and will be used to assess the accuracy of other diagnostic approaches
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Participants will be assessed within an average period of 48 hours of presenting to study primary healthcare centres
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Hospitalisation (yes/no)
기간: Within 30 days of first consultation
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This will be assessed for all study participants with either a malaria or pneumonia diagnosis as part of an epidemiological study
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Within 30 days of first consultation
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Death (yes/no)
기간: Within 30 days of first consultation
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This will be assessed for all study participants with either a malaria or pneumonia diagnosis as part of an epidemiological study
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Within 30 days of first consultation
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공동 작업자 및 조사자
수사관
- 수석 연구원: Kelly O Elimian, MSc, University of Nottingham & University of Benin
- 연구 책임자: Puja R Myles, PhD, University of Nottingham
- 연구 책임자: Catherine Pritchard, PhD, University of Nottingham
- 연구 책임자: Ayebo Sadoh, PhD, University of Benin
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .