Invasive Disease Caused by Group A Streptococcus (GAS) (DICAR)

NCT ID: NCT03507101

Last Updated: 2023-04-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2024-12-31

Brief Summary

The goal of this study is to gain important knowledge on the pathogenesis and prognostic factors in severe invasive group A streptococcal (GAS) infections, as well as the effects of individual characteristics of both the pathogen and the patient on disease severity. The aim is to recruit a minimum of 60 patients from Tampere and Turku University Hospitals in 2-3 years to gather a suitably wide spectrum of manifestations of the disease, and gather genetic, transcriptomic and diagnostic data on both the patients and pathogens in an effort to further our understanding of the pathogenesis of severe invasive GAS disease.

Detailed Description

Invasive group A streptococcal (GAS) infection is a severe, life threatening disease. New prognostic markers are needed to better identify patients at risk of severe complications to better improve their care. By advancing understanding of the mechanisms of severe disease, treatments may be found to hinder the processes behind them. It is likely that different individuals react differently to the same microbe.

From previous incidence data the investigators have estimated that it will be possible to recruit a minimum of 60 patients over the course of 2-3 years from Tampere and Turku University Hospitals. This sample size should contain a reasonably wide array of infections with varying stages of severity. The investigators will then gather genetic and transcriptomic data on these patients at three time points, as well as salival samples for antibody analysis, and throat cultures to screen for carriage of the pathogen in question. The genome of all the GAS strains obtained from the patients will also be sequenced. From this the investigators hope to derive information pertaining to the interplay of the patients immunologic response and the pathogens inherent characteristics.

Conditions

Invasive Group A Beta-Haemolytic Streptococcal Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Invasive GAS infection study patients

No intervention

Intervention Type: OTHER

No particular intervention or exposure is of particular interest

Interventions

No intervention

No particular intervention or exposure is of particular interest

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adult patients who have been diagnosed with invasive group A streptococcal disease and are willing to participate

Exclusion Criteria

• Underage patients are excluded

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Turku University Hospital

OTHER_GOV

Sponsor Role: collaborator

University of Turku

OTHER

Sponsor Role: collaborator

Tampere University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ville Kaila

Clinical investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jaana Syrjänen, PhD

Role: STUDY_DIRECTOR

Tampere University Hospital

Locations

Tampere university hospital

Tampere, Pirkanmaa, Finland

Turku university hospital

Turku, Southwest Finland, Finland

Countries

Finland

References

Kailankangas V, Vilhonen J, Grondahl-Yli-Hannuksela K, Rantakokko-Jalava K, Seiskari T, Auranen K, Lonnqvist E, Virolainen M, Hyyrylainen HL, Oksi J, Syrjanen J, Vuopio J. Presence of Streptococcus pyogenes in the throat in invasive Group A Streptococcal disease: a prospective two-year study in two health districts, Finland. Infect Dis (Lond). 2023 Jun;55(6):405-414. doi: 10.1080/23744235.2023.2192287. Epub 2023 Apr 8.

Reference Type: DERIVED

PMID: 37029930 (View on PubMed)

Other Identifiers

DICAR

Identifier Type: -

Identifier Source: org_study_id