Invasive Group A Beta-Haemolytic Streptococcal DiseaseDICARNCT03507101
Invasive Disease Caused by Group A Streptococcus (GAS) (DICAR)
An observational study of Invasive Group A Beta-Haemolytic Streptococcal Disease, run by Tampere University Hospital at 2 sites in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Group A Beta-Haemolytic Streptococcal Disease
- How many people
- 45 participants
- Where
- 2 sitesFinland
- Study dates
- 1 Aug 2018to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adult patients who have been diagnosed with invasive group A streptococcal disease and are willing to participate
Who cannot join
- Underage patients are excluded
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Tampere university hospital
Tampere, Pirkanmaa, 33521
Turku university hospital
Turku, Southwest Finland, 20521
About this study
Official title: 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.
Read the 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.
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No particular intervention or exposure is of particular interest
| Study group | Role | What they receive |
|---|---|---|
| Invasive GAS infection study patients | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe invasive GAS disease
GAS infection leading to death, complications or disability
Measured: Four month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2018
- Study start1 Aug 2018
- Primary completion1 Jul 2021
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Invasive Group A Beta-Haemolytic Streptococcal DiseaseStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Turku University Hospital, University of Turku
- Responsible party
- Principal investigator, Ville Kaila, Tampere University Hospital
- Investigators
- Jaana Syrjänen, PhD, Study director, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03507101
- Sponsor's protocol ID
- DICAR
- Acronym
- DICAR
- Status last verified
- Apr 2023
- First submitted
- 19 Apr 2018
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
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.
PubMed 37029930
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Invasive Disease Caused by Group A Streptococcus (GAS) - a Prospective Study (DICAR)
- ClinicalTrials.gov ID
- NCT03507101
- Acronym / sponsor ID
- DICAR / DICAR
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Turku University Hospital, University of Turku
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- Dec 2024 (estimated)
- First posted
- 24 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Invasive GAS infection study patients | – | Other: No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Adult patients who have been diagnosed with invasive group A streptococcal disease and are willing to participate
Key exclusion criteria (1 listed)
- Underage patients are excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo particular intervention or exposure is of particular interest | Other | Invasive GAS infection study patients |
Primary outcome
Severe invasive GAS disease
Time frame: Four month follow up
GAS infection leading to death, complications or disability
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Derived from this study: PubMed 37029930Kailankangas 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.
- Individual participant dataSharing planned: Undecided. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaana Syrjänen, PhD study director
Tampere University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Group A Beta-Haemolytic Streptococcal Disease, run by Tampere University Hospital at 2 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe invasive GAS disease (time frame: Four month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03507101, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2023.