- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
Edo State
-
Benin City, Edo State, Nigeria
- Health Services Department, University of Benin
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Éventuel
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Malaria confirmed by microscopy (yes/no)
Délai: 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)
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Hospitalisation (yes/no)
Délai: 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)
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Kelly O Elimian, MSc, University of Nottingham & University of Benin
- Directeur d'études: Puja R Myles, PhD, University of Nottingham
- Directeur d'études: Catherine Pritchard, PhD, University of Nottingham
- Directeur d'études: Ayebo Sadoh, PhD, University of Benin
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- HA.577/Vol. II/126
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .