- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
-
-
Edo State
-
Benin City, Edo State, Nigeria
- Health Services Department, University of Benin
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Coorte
- Prospettive temporali: Prospettiva
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Malaria confirmed by microscopy (yes/no)
Lasso di tempo: 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)
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Hospitalisation (yes/no)
Lasso di tempo: 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)
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Kelly O Elimian, MSc, University of Nottingham & University of Benin
- Direttore dello studio: Puja R Myles, PhD, University of Nottingham
- Direttore dello studio: Catherine Pritchard, PhD, University of Nottingham
- Direttore dello studio: Ayebo Sadoh, PhD, University of Benin
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- HA.577/Vol. II/126
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .