A Comparison of Diagnostic Approaches for Malaria and Pneumonia

• Conditions: Malaria; Pneumonia

• Registration Number: NCT02482116
• Lead Sponsor: University of Nottingham

Brief 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.

Study Timeline

• Study First Submitted: 2015-06-22
• Study First Submitted QC: 2015-06-25
• Study First Posted: 2015-06-26
• Study Start: 2015-08
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-30
• Last Update Posted: 2016-08-31
• Primary Completion: 2017-07
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Malaria confirmed by microscopy (yes/no)	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)	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

Secondary Outcome Measures

Name	Time	Method
Hospitalisation (yes/no)	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
Death (yes/no)	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

Trial Locations

Locations (1)

Health Services Department, University of Benin; 🇳🇬 Benin City, Edo State, Nigeria