Overview

This trial is active, not recruiting.

Conditions malaria, pneumonia
Treatment malaria or pneumonia diagnosis
Sponsor University of Nottingham
Collaborator University of Benin
Start date August 2015
End date July 2017
Trial size 1000 participants
Trial identifier NCT02482116, HA.577/Vol. II/126

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Malaria confirmed by microscopy (yes/no)
time frame: 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)
time frame: Participants will be assessed within an average period of 48 hours of presenting to study primary healthcare centres

Secondary Outcomes

Measure
Hospitalisation (yes/no)
time frame: Within 30 days of first consultation
Death (yes/no)
time frame: Within 30 days of first consultation

Eligibility Criteria

Male or female participants from 2 months up to 4 years old.

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:

Additional Information

Official title 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
Principal investigator Kelly O Elimian, MSc
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University of Nottingham.