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

Invasive Disease Caused by Group A Streptococcus (GAS) - a Prospective Study (DICAR)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Invasive Group A Beta-Haemolytic Streptococcal Disease
• Intervention / Treatment: Other: No intervention

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.

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• Finland
  • Pirkanmaa
    • Tampere, Pirkanmaa, Finland, 33521
      • Tampere University Hospital
  • Varsinais-Suomi
    • Turku, Varsinais-Suomi, Finland, 20521
      • Turku University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Invasive GAS infection study patients	Other: No intervention; No particular intervention or exposure is of particular interest

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severe invasive GAS disease	GAS infection leading to death, complications or disability	Four month follow up

Collaborators and Investigators

• Sponsor: Tampere University Hospital
• Collaborators: Turku University Hospital; University of Turku
• Investigators: Study Director: Jaana Syrjänen, PhD, Tampere University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Actual): July 1, 2021
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: April 19, 2018
• First Submitted That Met QC Criteria: April 19, 2018
• First Posted (Actual): April 24, 2018

Study Record Updates

• Last Update Posted (Actual): April 14, 2023
• Last Update Submitted That Met QC Criteria: April 13, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: DICAR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: In the future it may be possible to make this data available to continue research under this topic. In such a case a request would have to be made through the review board of the Tampere University Hospital.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No