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

NCT03507101 | Unknown

• 1 other identifier: DICAR
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 2

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.

Conditions

Invasive Group A Beta-Haemolytic Streptococcal Disease

Outcome Measures

Primary Outcomes (1)

• Severe invasive GAS disease

  GAS infection leading to death, complications or disability

  Four month follow up

Study Arms (1)

Invasive GAS infection study patients

Other: No intervention

Interventions

No intervention OTHER

No particular intervention or exposure is of particular interest

Invasive GAS infection study patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A minimum of 60 patients from Tampere and Turku University Hospitals who contract invasive group A streptococcal disease within our recruitment period. The size of the study population has been difficult to calculate exactly, but the investigators have gauged the size according to previous epidemiological data to have a population that has a wide variety of disease courses to get a good understanding of the pathogenesis, and that can be recruited within 2-3 years.

You may qualify if:

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

You may not qualify if:

• Underage patients are excluded

Sponsors & Collaborators

• Tampere University Hospital: lead
• Turku University Hospital: collaborator
• University of Turku: collaborator

Study Sites (2)

Tampere university hospital

Tampere, Pirkanmaa, 33521, Finland

Location

Turku university hospital

Turku, Southwest Finland, 20521, Finland

Location

Related Publications (1)

• 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.

  PMID: 37029930 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

The investigators will obtain DNA and RNA samples from all study patients for genetic and transcriptomic analysis to assess inherited risk factors and immunologic response.

Study Officials

• Jaana Syrjänen, PhD

  Tampere University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical investigator

Study Record Dates

• First Submitted: April 19, 2018
• First Posted: April 24, 2018
• Study Start: August 1, 2018
• Primary Completion: July 1, 2021
• Study Completion: December 1, 2024
• Last Updated: April 14, 2023

Record last verified: 2023-04

Locations

FI (2)