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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
-
-
Edo State
-
Benin City, Edo State, Nigeria
- Health Services Department, University of Benin
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-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: Kohorte
- Zeitperspektiven: Interessent
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Malaria confirmed by microscopy (yes/no)
Zeitfenster: Participants will be assessed within an average period of 24 hours of presenting to study primary healthcare centres
|
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)
Zeitfenster: Participants will be assessed within an average period of 48 hours of presenting to study primary healthcare centres
|
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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Hospitalisation (yes/no)
Zeitfenster: Within 30 days of first consultation
|
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)
Zeitfenster: Within 30 days of first consultation
|
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
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Kelly O Elimian, MSc, University of Nottingham & University of Benin
- Studienleiter: Puja R Myles, PhD, University of Nottingham
- Studienleiter: Catherine Pritchard, PhD, University of Nottingham
- Studienleiter: Ayebo Sadoh, PhD, University of Benin
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- HA.577/Vol. II/126
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