A Comparison of Diagnostic Approaches for Malaria and Pneumonia

NCT ID: NCT02482116

Last Updated: 2016-08-31

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2017-07-31

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.

Conditions

Malaria; Pneumonia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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)

Intervention Type: OTHER

Other Intervention Names

Integrated Management of Childhood Illness (IMCI) guidelines; Giemsa microscopy; Chest x-ray; Rapid diagnostic test for malaria; Lay-diagnosis of malaria & pneumonia

Eligibility Criteria

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

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 4 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Benin

OTHER

Sponsor Role: collaborator

University of Nottingham

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kelly O Elimian, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Nottingham & University of Benin

Puja R Myles, PhD

Role: STUDY_DIRECTOR

University of Nottingham

Catherine Pritchard, PhD

Role: STUDY_DIRECTOR

University of Nottingham

Ayebo Sadoh, PhD

Role: STUDY_DIRECTOR

University of Benin

Locations

Health Services Department, University of Benin

Benin City, Edo, Nigeria

Countries

Nigeria

Other Identifiers

HA.577/Vol. II/126

Identifier Type: -

Identifier Source: org_study_id