Study on the Burden of Influenza-related Hospitalizations and Emergency Room (ER) Visits in Children in Spain
12 juin 2018 mis à jour par: GlaxoSmithKline
Burden of Influenza-related Hospitalizations and Emergency Room Visits in Children in Spain
This study aims to quantify the inpatient and ER visits burden of laboratory-confirmed influenza, and compare the clinical features, severity, complications, risk factors and socioeconomic impact of influenza in children presenting with acute respiratory illness (ARI) and/or isolated fever, with or without laboratory-confirmed influenza.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
The total medical cost associated with each hospitalization or ER visit will also be calculated at the end of this study.
The study will be conducted from October, 2010, until May, 2011. Each subject will be followed-up for 21-30 days via telephone. The follow-up medical chart review will preferably be performed within 7 days after the telephone contact.
Type d'étude
Interventionnel
Inscription (Réel)
501
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Bilbao, Espagne, 48013
- GSK Investigational Site
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
Pas plus vieux que 15 ans (Enfant)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Subjects for whom the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol.
- A male or female <15 years of age at the time of study entry. A subject will become ineligible on his/her 15th birthday.
- Signed informed consent from the parents or guardians of the subject and signed assent from children ≥ 12 years old.
Presenting with a sudden onset clinical process comprising :
- Isolated fever defined as: oral temperature ≥ 37.5°C / axillary temperature ≥ 37.5°C / Rectal temperature ≥ 38°C / tympanic temperature on oral setting ≥ 37.5°C / tympanic temperature on rectal setting ≥ 38°C without an obvious cause.
And/or
- ARI defined as one or more of the following symptoms: sore throat, coryza, cough, breathing difficulties.
Exclusion Criteria:
• Children in foster care.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Autre: Influenza Group
Children <15 years of age hospitalized for or presenting to an ER for acute ARI and/or isolated fever during the influenza season.
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Samples will be tested to quantify the inpatient and ER visits burden of laboratory-confirmed influenza.
Log Sheet will be used to collected data on a monthly basis for the following age groups: < 6 months; 6-23 months; 24-59 months; > 5 years.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Number of Subjects With Laboratory-confirmed Influenza Presenting With an Acute Respiratory Illness (ARI) and/or Isolated Fever
Délai: Day 0 till Day 28-37
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ARI was defined as one or more of the following symptoms: sore throat (in children greater than or equal to (≥) 3 years old), coryza (runny nose), cough, breathing difficulties.
Isolated fever was defined as: oral temperature ≥37.5°C / axillary temperature ≥37.5°C / Rectal temperature ≥38°C / tympanic temperature on oral setting ≥37.5°C / tympanic temperature on rectal setting ≥38°C without an obvious cause.
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Day 0 till Day 28-37
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Direct Medical Cost Per Hospitalization or ER Visit With Laboratory-confirmed Influenza
Délai: Day 0 till Day 28-37
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Ward specific room charge and Intensive Care Unit (ICU) were computed as daily charge multiplied by the number of days.
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Day 0 till Day 28-37
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Number of Subjects With Other Laboratory-confirmed Respiratory Viruses
Délai: Day 0 till Day 28-37
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Among the other laboratory-confirmed respiratory viruses there were:adenovirus, respiratory syncytial virus, parainfluenza virus 1, 2 and 3, metapneumovirus, bocavirus, rhinovirus or coronavirus.
The outcome was assessed in subjects with an acute respiratory illness (ARI) and/or isolated fever episode.
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Day 0 till Day 28-37
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Number of Subjects With Fatal Outcomes
Délai: Day 0 till Day 28-37
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Deaths from ARI and/or fever episodes by laboratory-confirmed influenza status were assessed.
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Day 0 till Day 28-37
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Number of Subjects With Secondary Bacterial Infections
Délai: Day 0 till Day 28-37
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The outcome assessed the various complications by laboratory-confirmed influenza status.
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Day 0 till Day 28-37
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Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status
Délai: Day 0 till Day 28-37
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Risk factors were classified as pre-existing conditions, breast-feeding status and day-care status.
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Day 0 till Day 28-37
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Number of Days of Hospitalization
Délai: Day 0 till Day 28-37 (between October 2010 until May 2011)
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The outcomes was assessed in subjects with laboratory-confirmed influenza status
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Day 0 till Day 28-37 (between October 2010 until May 2011)
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Number of Subjects Using Any ARI and/or Fever Related Medication Taken Prior to Hospitalization or ER Visit by Laboratory-confirmed Influenza Status
Délai: Day 0 till Day 28-37
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ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.
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Day 0 till Day 28-37
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Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed During Hospitalization or ER Visit by Laboratory-confirmed Influenza Status
Délai: Day 0 till Day 28-37
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ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.
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Day 0 till Day 28-37
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Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed Since Hospitalization or ER Visit by Laboratory-confirmed Influenza Status
Délai: Day 0 till Day 28-37
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ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.
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Day 0 till Day 28-37
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Number of Subjects Using Any Non-prescribed ARI and/or Fever Related Medication Taken Since Hospitalization or ER Visit
Délai: Day 0 till Day 28-37
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ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.
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Day 0 till Day 28-37
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Number of Days of School Absenteeism
Délai: Day 0 till Day 28-37
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School absenteeism was assessed among patients during the follow-up period by laboratory-confirmed influenza status.
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Day 0 till Day 28-37
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Number of Days of Parent or Caregiver Time Off Work
Délai: Day 0 till Day 28-37
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This outcome assessed absenteeism among caregivers to provide patient care during the follow-up period by laboratory-confirmed influenza status.
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Day 0 till Day 28-37
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Number of Subjects With Household Members With Influenza-like Illness
Délai: Day 0 till Day 28-37
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This outcome assessed the number of cases with household contacts presenting influenza like illness symptoms during the follow-up period by laboratory-confirmed influenza status.
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Day 0 till Day 28-37
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Proportion of Household Members Presenting Influenza Like Illness Symptoms (ARI and/or Isolated Fever)
Délai: Day 0 till Day 28-37
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This outcome assessed the proportion of influenza like illness (ILI) among household members of children < 15 years with and without laboratory-confirmed influenza.
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Day 0 till Day 28-37
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
23 novembre 2010
Achèvement primaire (Réel)
23 mai 2011
Achèvement de l'étude (Réel)
23 mai 2011
Dates d'inscription aux études
Première soumission
3 mai 2012
Première soumission répondant aux critères de contrôle qualité
3 mai 2012
Première publication (Estimation)
7 mai 2012
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
27 juillet 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
12 juin 2018
Dernière vérification
1 juin 2018
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 114004
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