Clinical trial NCT02482116: A Comparison of Diagnostic Approaches for Malaria and Pneumonia
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Malaria
Pneumonia
Keywords: malaria
pneumonia
Nigeria
IMCI
diagnosis
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: University of Benin
First posted: 2015-06-26
Enrollment: 1000
Sex: ALL
Minimum age (years): 2
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Malaria confirmed by microscopy (yes/no)
timeFrame: Participants will be assessed within an average period of 24 hours of presenting to study primary healthcare centres
measure: Pneumonia confirmed by chest x-ray (yes/no)
timeFrame: Participants will be assessed within an average period of 48 hours of presenting to study primary healthcare centres
Secondary outcomes:
measure: Hospitalisation (yes/no)
timeFrame: Within 30 days of first consultation
measure: Death (yes/no)
timeFrame: Within 30 days of first consultation
Other outcomes:
Locations:
city: Benin City
country: Nigeria
facility: Health Services Department, University of Benin
state: Edo State
Study officials:
affiliation: University of Nottingham & University of Benin
name: Kelly O Elimian, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Nottingham
name: Puja R Myles, PhD
role: STUDY_DIRECTOR
affiliation: University of Nottingham
name: Catherine Pritchard, PhD
role: STUDY_DIRECTOR
affiliation: University of Benin
name: Ayebo Sadoh, PhD
role: STUDY_DIRECTOR
References: