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

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.

Study Overview

• Status: Unknown
• Conditions: Pneumonia; Malaria
• Intervention / Treatment: Other: malaria or pneumonia diagnosis

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 Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• Nigeria
  • Edo State
    • Benin City, Edo State, Nigeria
      • Health Services Department, University of Benin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 6 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population are children aged 2 months to four years old who are residents in the catchment local government area of study primary healthcare centres in Benin City, Edo State, Nigeria.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Malaria confirmed by microscopy (yes/no)	This is the gold standard diagnosis for malaria and will be used to assess the accuracy of other diagnostic approaches	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)	This is the gold standard test for pneumonia and will be used to assess the accuracy of other diagnostic approaches	Participants will be assessed within an average period of 48 hours of presenting to study primary healthcare centres

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalisation (yes/no)	This will be assessed for all study participants with either a malaria or pneumonia diagnosis as part of an epidemiological study	Within 30 days of first consultation
Death (yes/no)	This will be assessed for all study participants with either a malaria or pneumonia diagnosis as part of an epidemiological study	Within 30 days of first consultation

Collaborators and Investigators

• Sponsor: University of Nottingham
• Collaborators: University of Benin
• Investigators: Principal Investigator: Kelly O Elimian, MSc, University of Nottingham & University of Benin; Study Director: Puja R Myles, PhD, University of Nottingham; Study Director: Catherine Pritchard, PhD, University of Nottingham; Study Director: Ayebo Sadoh, PhD, University of Benin

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Anticipated): July 1, 2017
• Study Completion (Anticipated): July 1, 2017

Study Registration Dates

• First Submitted: June 22, 2015
• First Submitted That Met QC Criteria: June 25, 2015
• First Posted (Estimate): June 26, 2015

Study Record Updates

• Last Update Posted (Estimate): August 31, 2016
• Last Update Submitted That Met QC Criteria: August 30, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: pneumonia; diagnosis; malaria; Nigeria; IMCI
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Pneumonia; Malaria
• Other Study ID Numbers: HA.577/Vol. II/126