Date de modification : 05/09/2017 | Version : 2 | ID : 2841
Général | |
Identification | |
Nom détaillé | Observational study of the therapeutic strategy in the management of acute sinusitis in primary care |
Sigle ou acronyme | ABSINTHE |
Numéro d'enregistrement (ID-RCB ou EUDRACT, CNIL, CPP, etc.) | CCTI-RS 04.342, CNIL 904410 |
Thématiques générales | |
Domaine médical |
Otolaryngology or ENT |
Déterminants de santé |
Iatrogenic |
Mots-clés | telithromycin, antibiotic, ENT, Ketek, management, effectiveness, therapeutic strategies, recommendations, pharmacoepidemiology, cohort, Department of Pharmacology, Bordeaux |
Responsable(s) scientifique(s) | |
Nom du responsable | Moore |
Prénom | Nicholas |
Adresse | Bât du Tondu - Case 41 - 146, Rue Léo Saignat - 33076 BORDEAUX Cedex |
Téléphone | + 33 (0)5 57 57 46 75 |
nicholas.moore@pharmaco.u-bordeaux2.fr | |
Laboratoire | Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen |
Organisme | Université Bordeaux |
Collaborations | |
Financements | |
Financements |
Mixed |
Précisions | Laboratoire Sanofi-Aventis (soutien inconditionnel) - Sanofi-Aventis (unconditional support) |
Gouvernance de la base de données | |
Organisation(s) responsable(s) ou promoteur | INSERM |
Statut de l’organisation |
Secteur Public |
Contact(s) supplémentaire(s) | |
Caractéristiques | |
Type de base de données | |
Type de base de données |
Study databases |
Base de données issues d'enquêtes, précisions |
Longitudinal study (except cohorts) |
Origine du recrutement des participants |
A selection of health care professionals |
Le recrutement dans la base de données s'effectue dans le cadre d'une étude interventionnelle |
No |
Informations complémentaires concernant la constitution de l'échantillon | A database of general practitioners and non-hospital ENT specialists provided by Wanadoo was used for selection of physicians. General practitioners and ENT specialists were to include prospectively over a period of 4 weeks patients with an episode of acute sinusitis diagnosed according to criteria of the physician. To avoid conducting the study over a period with marked ecological features such as a period of epidemic influenza or respiratory syncytial virus that can interfere with diagnosis and / or treatment of acute sinusitis, the study was conducted over two four-week periods: March / April and September / October. Each physician was to include the first patients meeting the study inclusion criteria (5 during the first wave of inclusion and 6 in the second). |
Objectif de la base de données | |
Objectif principal | The study objectives were to describe the management of acute sinusitis in real-life conditions of prescription and to evaluate the effectiveness of the initial therapeutic strategy. |
Critères d'inclusion | Patient consulting for acute sinusitis diagnosed according to criteria of the practitioner; Patient without a previous episode of acute sinusitis during the two months preceding diagnosis; Patient aged 18 years and over; Patient agreeing to participate in the study; Patient not included in a clinical trial (Huriet-Sérusclat); Patient who may be followed for two months; Patient showing no severe active disease (life-threatening in the next three months). |
Type de population | |
Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
Population concernée |
Sick population |
Sexe |
Male Woman |
Champ géographique |
National |
Détail du champ géographique | General practitioners and ENT specialists in metropolitan France |
Collecte | |
Dates | |
Année du premier recueil | 2005 |
Année du dernier recueil | 2005 |
Taille de la base de données | |
Taille de la base de données (en nombre d'individus) |
[1000-10 000[ individuals |
Détail du nombre d'individus | 5693 |
Données | |
Activité de la base |
Data collection completed |
Type de données recueillies |
Clinical data Declarative data |
Données cliniques, précisions |
Direct physical measures |
Données déclaratives, précisions |
Paper self-questionnaire |
Existence d’une biothèque |
No |
Paramètres de santé étudiés |
Health event/morbidity Health event/mortality Health care consumption and services |
Consommation de soins, précisions |
Medicines consumption |
Modalités | |
Mode de recueil des données | Patients included were the subject of collection of indirectly personal medical data (medical questionnaire completed by the physician at inclusion and 10 days and 2 months after inclusion) and they also had to complete a self-administered within 10 days following inclusion. Participating physicians were also asked to identify and register all patients with an episode of acute sinusitis (with a maximum of 20 patients). |
Suivi des participants |
Yes |
Détail du suivi | Patients were followed for 2 months with an evaluation point at 10 days and 2 months after diagnosis. These assessment points concerned the evolution of sinusitis and associated care (antibiotics, drainage, other). |
Appariement avec des sources administratives |
No |
Valorisation et accès | |
Valorisation et accès | |
Lien vers le document | http://tinyurl.com/Pubmed-ABSINTHE |
Description | List of publications in Pubmed |
Accès | |
Charte d'accès aux données (convention de mise à disposition, format de données et délais de mise à disposition) | A final study report was submitted to the funder. The final study report and scientific communications (posters, papers, ...) are validated by the study Scientific Committee. Ownership of study data is the subject of an agreement between the University of Bordeaux Segalen and the funder. Terms for third-party access to the database are to be defined. |
Accès aux données agrégées |
Access on specific project only |
Accès aux données individuelles |
Access on specific project only |
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