Invasive Group A Streptococcal Disease in a Spanish County Hospital
Invasive Streptococcus Pyogenes Disease: Epidemiology, Clinical Characteristics, Prognostic Factors, and Temporal Trends. A Retrospective Observational Study
The goal of this observational study is to describe how often invasive infections caused by Streptococcus pyogenes (group A streptococcus) occurred, how they presented, how they were treated, and how patients did, in patients of any age treated at Hospital Residència Sant Camil between 2018 and 2024. The main questions it aims to answer are:
- What was the annual incidence of invasive group A streptococcal disease between 2018 and 2024, and did it increase after the COVID-19 pandemic?
- What are the clinical characteristics, treatment, and outcomes of these patients, and how do they compare with the patients treated at the same hospital between 2008 and 2012?
- Which clinical factors are associated with in-hospital death and with admission to the intensive care unit?
Aperçu de l'étude
Statut
Description détaillée
Invasive group A streptococcal disease (iGAS) is a severe infection with high morbidity and mortality, including bacteremia, necrotizing fasciitis, streptococcal toxic shock syndrome, pneumonia, empyema, septic arthritis, and meningitis, with reported mortality of 10% to 20%. After a marked decrease in 2020 and 2021, surveillance systems reported a significant increase in cases in 2022 and 2023, which led to alerts from the World Health Organization, the European Centre for Disease Prevention and Control, and national authorities. Most evidence comes from national registries or tertiary hospitals, and data from Spanish county hospitals are scarce.
This single-center retrospective cohort study will include all episodes of iGAS diagnosed at Hospital Residència Sant Camil (Consorci Sanitari de l'Alt Penedès i Garraf) between January 1, 2018, and December 31, 2024. iGAS is defined as isolation of S. pyogenes from a normally sterile site, necrotizing fasciitis with isolation of S. pyogenes from deep tissue, or streptococcal toxic shock syndrome (CDC criteria) with microbiological isolation of S. pyogenes. Cases will be identified from all positive S. pyogenes isolates in the Microbiology Service records, and data will be collected from the electronic medical record into an electronic case report form (REDCap): demographics, comorbidities, site and acquisition of infection, bacteremia, toxic shock syndrome, polymicrobial infection, antibiotic treatment, ICU admission, and in-hospital mortality. The expected sample is 60 to 70 patients.
Annual incidence will be calculated using the reference population of the health area as the denominator. The 2018-2024 cohort will be compared with the historical 2008-2012 cohort from a previous study at the same hospital using the chi-square or Fisher's exact test and Student's t or Mann-Whitney U test. Bivariate analyses will assess the association between clinical characteristics and in-hospital mortality and ICU admission.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
Barcelona
-
Sant Pere de Ribes, Barcelona, Espagne, 08810
- Hospital Residència Sant Camil
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
All patients of any age with an episode of invasive Streptococcus pyogenes disease diagnosed between January 1, 2018, and December 31, 2024, and initially treated at Hospital Residència Sant Camil, identified from the Microbiology Service records.
La description
Inclusion Criteria:
- Patients of any age and sex
- Diagnosis of invasive S. pyogenes disease, defined by any of the following: isolation of S. pyogenes from a normally sterile sample; necrotizing fasciitis with isolation of S. pyogenes from deep tissue; or streptococcal toxic shock syndrome with microbiological isolation of S. pyogenes
- Episode diagnosed between January 1, 2018, and December 31, 2024
- Initial care of the episode at Hospital Residència Sant Camil
- Sufficient clinical information available to obtain the study variables
Exclusion Criteria:
- Episodes that do not meet the protocol definition of invasive S. pyogenes disease
- Clinical or microbiological records with insufficient information to confirm the diagnosis or obtain the main study variables
- Duplicate episodes corresponding to the same infectious process
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: RETROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
|---|
|
2018-2024 cohort
|
|
2008-2012 historical cohort
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Annual incidence of invasive Streptococcus pyogenes disease
Délai: Each calendar year from 2018 to 2024
|
Each calendar year from 2018 to 2024
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
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
- Maladies musculo-squelettiques
- Processus pathologiques
- Infections
- État septique
- Syndrome de réponse inflammatoire systémique
- Inflammation
- Infections bactériennes à Gram positif
- Infections bactériennes
- Infections bactériennes et mycoses
- Conditions pathologiques, signes et symptômes
- Fasciite
- Bactériémie
- Infections streptococciques
- Fasciite, nécrosante
Autres numéros d'identification d'étude
- CSAPG-99
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research purposes and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).
Délai de partage IPD
After publication of main results of the study.
Critères d'accès au partage IPD
IPD will be shared only for scientific research purposes and following the Spanish and European Union normative law about data protection. The requirements will be directed to the IP of the study. The IP will evaluate the request to verify and evaluate the data that is requested and the purposes for which it is requested. Next, the IP will transfer the request to the promotor center the study for the final decision.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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 .