Invasive Group A Beta-Haemolytic Streptococcal DiseasePEGASUSNCT06058117
Paediatric European Group A Streptococcal United Study.
An observational study of Invasive Group A Beta-Haemolytic Streptococcal Disease, run by Noordwest Ziekenhuisgroep at 1 site in Netherlands.
Trial summary
Introduction Since 2022 there are reports of a rapid increase in invasive group A streptococcal infections (iGAS) in children in some but not all European countries. Detailed information on this increase is lacking. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Invasive Group A Beta-Haemolytic Streptococcal Disease
- How many people
- 500 participants
- Where
- 1 siteNetherlands
- Study dates
- 20 Sep 2023to 1 Dec 2025
- How long will I take part?
- 3 Months
- 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 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Definitions Confirmed iGAS infection: * Clinical presentation consistent with iGAS* AND * Isolation of group A streptococcus by culture or PCR or antigen detection test from a normally sterile body site Probable iGAS infection: * Clinical presentation consistent with STSS or necrotizing fasciitis * AND * Isolation of group A streptococcus by culture or PCR or antigen detection test from a non-sterile body site AND * No evidence of other pathogen explaining the clinical presentation * Clinical presentation consistent with iGAS: Clinically severe illness, such as sepsis, septic shock, STSS, pneumonia, meningitis, arthritis, osteomyelitis, myositis or necrotizing fasciitis
- All children (1 month-18 years)
- attending the Emergency Department and/or admitted to the participating hospital - with iGAS infection or other invasive or emergent infectious disease.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Noordwest Ziekenhuisgroep
Alkmaar, North Holland, 1815 JD
Dorine Borensztajn, MD, PhD, MSc
About this study
Official title: PEGASUS: Paediatric European Group A Streptococcal United Study.
Introduction Since 2022 there are reports of a rapid increase in invasive group A streptococcal infections (iGAS) in children in some but not all European countries. Detailed information on this increase is lacking. Furthermore, an increase in other invasive infections as well as the emergence of novel pathogens and disease entities is seen, such as MIS-C and severe hepatitis of unknown origin.
Aims To set up a European research network and describe the incidence, risk factors, clinical phenotypes, microbiology and resistance, treatment, and outcomes of iGAS in children across Europe. The network will subsequently be utilized for early alerting regarding the rise of other invasive and emerging infections in children. It will enable swift data collection pertaining to patient characteristics, presentation, progression, and treatment.
Read more
Methods International, retrospective cohort and observational surveillance study of children 0-18y attending the ED or admitted to the hospital with iGAS. Clinical and microbiological data, national vaccination schedules, and COVID non-pharmaceutical interventions (NPIs) will be collected and compared between countries. Subsequently, the network will be employed to raise alarms regarding the surge of other invasive infections or emerging infections in children. Anonymous data about these novel infections will be collected, similar to the data from iGAS (clinical characteristics and microbiological data). The study is a non-profit study.
Significance Our study will describe variation in the clinical phenotypes of iGAS, will aid in the understanding of its association with COVID NPIs and allow for comparison between countries. Furthermore, it will aid in early recognition of invasive and emergent infectious diseases in children and the reduction of outbreaks.
- 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 intervention, this is an observational study
| Study group | Role | What they receive |
|---|---|---|
| children with invasive group A streptococcal disease | children with invasive group A streptococcal disease or other invasive or emergent infectious disease Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
What is the incidence of iGAS in children before, during and after COVID NPIs in different European countries?
Measured: 2018-2025
Is there a change in clinical phenotypes and outcome during these periods?
Measured: 2018-2025
Secondary outcomes (5)
Is there a change in emm types and other virulence factors during these periods
Measured: 2018-2025
Are there differences in antimicrobial resistance between periods and between 4. Are there differences in antimicrobial resistance between periods and between countries
Measured: 2018-2025
Can we identify risk factors for iGAS infection (e.g., preceding infections, age)?
Measured: 2018-2025
Can we explain differences between countries (e.g., differences in vaccination strategies, NPIs or emm types)
Measured: 2018-2025
Can we use this research network for early alarming on other invasive and emergent infectious diseases in children
Measured: 2018-2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start20 Sep 2023
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Group A Beta-Haemolytic Streptococcal DiseaseStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Noordwest Ziekenhuisgroep
- Sponsor type
- University, hospital or other
- Collaborators
- European Society for Paediatric Infectious Diseases, Medical University of Graz, University Hospital Munich, National and Kapodistrian University of Athens, Mitera Hospital, Children's hospital Iceland, University of Padova, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Riga Stradins University, Maasstad Hospital, HagaZiekenhuis, Leiden University Medical Center, Wroclaw Medical University, University Medical Centre Ljubljana, Hospital Clinico Universitario de Santiago, Hospital Universitario 12 de Octubre, Hospital Universitario La Paz, Gregorio Marañón Hospital, Karolinska Institutet, Imperial College London, University of Liverpool, Newcastle University
- Responsible party
- Principal investigator, Dorine Borensztajn, Noordwest Ziekenhuisgroep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06058117
- Sponsor's protocol ID
- 1.2
- Acronym
- PEGASUS
- Status last verified
- Sep 2023
- First submitted
- 21 Sep 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PEGASUS: Paediatric European Group A Streptococcal United Study.
- ClinicalTrials.gov ID
- NCT06058117
- Acronym / sponsor ID
- PEGASUS / 1.2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Noordwest ZiekenhuisgroepUniversity, hospital or other
- Collaborators
- European Society for Paediatric Infectious Diseases, Medical University of Graz, University Hospital Munich, National and Kapodistrian University of Athens, Mitera Hospital, Children's hospital Iceland, University of Padova, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Riga Stradins University, Maasstad Hospital, HagaZiekenhuis, Leiden University Medical Center, Wroclaw Medical University, University Medical Centre Ljubljana, Hospital Clinico Universitario de Santiago, Hospital Universitario 12 de Octubre, Hospital Universitario La Paz, Gregorio Marañón Hospital, Karolinska Institutet, Imperial College London, University of Liverpool, Newcastle University
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 28 Sep 2023 (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.
Introduction Since 2022 there are reports of a rapid increase in invasive group A streptococcal infections (iGAS) in children in some but not all European countries. Detailed information on this increase is lacking. Furthermore, an increase in other invasive infections as well as the emergence of novel pathogens and disease entities is seen, such as MIS-C and severe hepatitis of unknown origin.
Aims To set up a European research network and describe the incidence, risk factors, clinical phenotypes, microbiology and resistance, treatment, and outcomes of iGAS in children across Europe. The network will subsequently be utilized for early alerting regarding the rise of other invasive and emerging infections in children. It will enable swift data collection pertaining to patient characteristics, presentation, progression, and treatment.
Methods International, retrospective cohort and observational surveillance study of children 0-18y attending the ED or admitted to the hospital with iGAS. Clinical and microbiological data, national vaccination schedules, and COVID non-pharmaceutical interventions (NPIs) will be collected and compared between countries. Subsequently, the network will be employed to raise alarms regarding the surge of other invasive infections or emerging infections in children. Anonymous data about these novel infections will be collected, similar to the data from iGAS (clinical characteristics and microbiological data). The study is a non-profit study.
Significance Our study will describe variation in the clinical phenotypes of iGAS, will aid in the understanding of its association with COVID NPIs and allow for comparison between countries. Furthermore, it will aid in early recognition of invasive and emergent infectious diseases in children and the reduction of outbreaks.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| children with invasive group A streptococcal disease | – | Other: No interventionchildren with invasive group A streptococcal disease or other invasive or emergent infectious disease |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Definitions Confirmed iGAS infection: * Clinical presentation consistent with iGAS* AND * Isolation of group A streptococcus by culture or PCR or antigen detection test from a normally sterile body site Probable iGAS infection: * Clinical presentation consistent with STSS or necrotizing fasciitis * AND * Isolation of group A streptococcus by culture or PCR or antigen detection test from a non-sterile body site AND * No evidence of other pathogen explaining the clinical presentation * Clinical presentation consistent with iGAS: Clinically severe illness, such as sepsis, septic shock, STSS, pneumonia, meningitis, arthritis, osteomyelitis, myositis or necrotizing fasciitis
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 intervention, this is an observational study | Other | children with invasive group A streptococcal disease |
Primary outcome
What is the incidence of iGAS in children before, during and after COVID NPIs in different European countries?
Time frame: 2018-2025
Is there a change in clinical phenotypes and outcome during these periods?
Time frame: 2018-2025
5 secondary outcomes
Is there a change in emm types and other virulence factors during these periods
Time frame: 2018-2025
Are there differences in antimicrobial resistance between periods and between 4. Are there differences in antimicrobial resistance between periods and between countries
Time frame: 2018-2025
Can we identify risk factors for iGAS infection (e.g., preceding infections, age)?
Time frame: 2018-2025
Can we explain differences between countries (e.g., differences in vaccination strategies, NPIs or emm types)
Time frame: 2018-2025
Can we use this research network for early alarming on other invasive and emergent infectious diseases in children
Time frame: 2018-2025
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: Undecided
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.
1 site 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 Noordwest Ziekenhuisgroep at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
Contact Dorine Borensztajn, MD, PhD, MSc (+31880855262, dm.borensztajn@nwz.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
What is the incidence of iGAS in children before, during and after COVID NPIs in different European countries? (time frame: 2018-2025). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2023.