A Comparison of Diagnostic Approaches for Malaria and Pneumonia

Malaria Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02482116
• Other study ID #: HA.577/Vol. II/126
• Status: Active, not recruiting
• Phase: N/A
• First received: June 22, 2015
• Last updated: August 30, 2016
• Start date: August 2015
• Est. completion date: July 2017

Study information

• Verified date: August 2016
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Months to 4 Years

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Malaria
• Pneumonia

Intervention

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)

Locations

Country	Name	City	State
Nigeria	Health Services Department, University of Benin	Benin City	Edo State

Sponsors (2)

Lead Sponsor	Collaborator
University of Nottingham	University of Benin

Country where clinical trial is conducted

Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No