- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02482116
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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
Edo State
-
Benin City, Edo State, Nigeria
- Health Services Department, University of Benin
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Kohort
- Tidsperspektiv: Blivande
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Malaria confirmed by microscopy (yes/no)
Tidsram: 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)
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Hospitalisation (yes/no)
Tidsram: 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)
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Kelly O Elimian, MSc, University of Nottingham & University of Benin
- Studierektor: Puja R Myles, PhD, University of Nottingham
- Studierektor: Catherine Pritchard, PhD, University of Nottingham
- Studierektor: Ayebo Sadoh, PhD, University of Benin
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- HA.577/Vol. II/126
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