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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03507101
Recruitment Status : Active, not recruiting
First Posted : April 24, 2018
Last Update Posted : October 19, 2021
Sponsor:
Collaborators:
Turku University Hospital
University of Turku
Information provided by (Responsible Party):
Ville Kaila, Tampere University Hospital

Study Description
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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.

Condition or disease Intervention/treatment
Invasive Group A Beta-Haemolytic Streptococcal Disease 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 Design
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Study Type : Observational
Actual Enrollment : 45 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Invasive Disease Caused by Group A Streptococcus (GAS) - a Prospective Study (DICAR)
Actual Study Start Date : August 1, 2018
Actual Primary Completion Date : July 1, 2021
Estimated Study Completion Date : December 2024
Groups and Cohorts
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Group/Cohort Intervention/treatment
Invasive GAS infection study patients Other: No intervention
No particular intervention or exposure is of particular interest


Outcome Measures
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Primary Outcome Measures :
  1. Severe invasive GAS disease [ Time Frame: Four month follow up ]
    GAS infection leading to death, complications or disability


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.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03507101


Locations
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Finland
Tampere university hospital
Tampere, Pirkanmaa, Finland, 33521
Turku university hospital
Turku, Varsinais-Suomi, Finland, 20521
Sponsors and Collaborators
Tampere University Hospital
Turku University Hospital
University of Turku
Investigators
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Study Director: Jaana Syrjänen, PhD Tampere University Hospital
More Information
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Responsible Party: Ville Kaila, Clinical investigator, Tampere University Hospital
ClinicalTrials.gov Identifier: NCT03507101    
Other Study ID Numbers: DICAR
First Posted: April 24, 2018    Key Record Dates
Last Update Posted: October 19, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No