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?
Studienübersicht
Status
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Barcelona
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Sant Pere de Ribes, Barcelona, Spanien, 08810
- Hospital Residència Sant Camil
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
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.
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: COHORT
- Zeitperspektiven: RETROSPECTIVE
Kohorten und Interventionen
Gruppe / Kohorte |
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2018-2024 cohort
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2008-2012 historical cohort
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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Annual incidence of invasive Streptococcus pyogenes disease
Zeitfenster: Each calendar year from 2018 to 2024
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Each calendar year from 2018 to 2024
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Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Bewegungsapparates
- Pathologische Prozesse
- Infektionen
- Sepsis
- Systemisches Entzündungsreaktionssyndrom
- Entzündung
- Grampositive bakterielle Infektionen
- Bakterielle Infektionen
- Bakterielle Infektionen und Mykosen
- Pathologische Zustände, Anzeichen und Symptome
- Fasziitis
- Bakteriämie
- Streptokokken-Infektionen
- Fasziitis, nekrotisierend
Andere Studien-ID-Nummern
- CSAPG-99
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
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).
IPD-Sharing-Zeitrahmen
After publication of main results of the study.
IPD-Sharing-Zugriffskriterien
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.
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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