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- Ensayo clínico 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
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Edo State
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Benin City, Edo State, Nigeria
- Health Services Department, University of Benin
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Malaria confirmed by microscopy (yes/no)
Periodo de tiempo: 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
|
|
Pneumonia confirmed by chest x-ray (yes/no)
Periodo de tiempo: 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
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Participants will be assessed within an average period of 48 hours of presenting to study primary healthcare centres
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Hospitalisation (yes/no)
Periodo de tiempo: 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)
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Kelly O Elimian, MSc, University of Nottingham & University of Benin
- Director de estudio: Puja R Myles, PhD, University of Nottingham
- Director de estudio: Catherine Pritchard, PhD, University of Nottingham
- Director de estudio: Ayebo Sadoh, PhD, University of Benin
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HA.577/Vol. II/126
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