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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (actual)
• Sponsor: University of Nottingham · Academic / Other
• Sex: All
• Age: 2 Months – 4 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Malaria
• Pneumonia

Interventions

Type	Name	Description
OTHER	malaria or pneumonia diagnosis	Diagnostic approaches for malaria (lay diagnosis, as per IMCI guidelines by trained primary healthcare workers, clinical diagnosis by medically qualified doctor, rapid diagnostic tests, Giemsa microscopy); Diagnostic approaches for pneumonia (lay diagnosis, as per IMCI guidelines by trained primary healthcare workers, clinical diagnosis by medically qualified doctor, chest x-ray)

Timeline

• Start date: 2015-08-01
• Primary completion: 2017-07-01
• Completion: 2017-07-01
• First posted: 2015-06-26
• Last updated: 2016-08-31

Locations

1 site across 1 country: Nigeria