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

Invasive Group A Beta-Haemolytic Streptococcal Disease Clinical Trial

— DICAR  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03507101
• Other study ID #: DICAR
• Status: Active, not recruiting
• Start date: August 1, 2018
• Est. completion date: December 2024

Study information

• Verified date: April 2023
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: December 2024
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Invasive Group A Beta-Haemolytic Streptococcal Disease

Intervention

Other:
• No intervention
No particular intervention or exposure is of particular interest

Locations

Country	Name	City	State
Finland	Tampere university hospital	Tampere	Pirkanmaa
Finland	Turku university hospital	Turku	Varsinais-Suomi

Sponsors (3)

Lead Sponsor	Collaborator
Tampere University Hospital	Turku University Hospital, University of Turku

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severe invasive GAS disease	GAS infection leading to death, complications or disability	Four month follow up