Paediatric European Group A Streptococcal United Study.
NCT06058117 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500
Last updated 2023-09-28
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. 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.
Conditions
- Invasive Group A Beta-Haemolytic Streptococcal Disease
Interventions
- OTHER
-
No intervention
no intervention, this is an observational study
Sponsors & Collaborators
-
European Society for Paediatric Infectious Diseases
collaborator OTHER -
Medical University of Graz
collaborator OTHER -
University Hospital Munich
collaborator OTHER -
National and Kapodistrian University of Athens
collaborator OTHER -
Mitera Hospital
collaborator OTHER -
Children's hospital Iceland
collaborator UNKNOWN -
University of Padova
collaborator OTHER -
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
collaborator OTHER -
Riga Stradins University
collaborator OTHER -
Maasstad Hospital
collaborator OTHER -
HagaZiekenhuis
collaborator OTHER -
Leiden University Medical Center
collaborator OTHER -
Wroclaw Medical University
collaborator OTHER -
University Medical Centre Ljubljana
collaborator OTHER -
Hospital Clínico Universitario de Santiago de Compostela
collaborator UNKNOWN -
Hospital Universitario 12 de Octubre
collaborator OTHER -
Hospital Universitario La Paz
collaborator OTHER -
Gregorio Marañón Hospital
collaborator OTHER - collaborator OTHER
-
Imperial College London
collaborator OTHER -
University of Liverpool
collaborator OTHER -
Newcastle University
collaborator OTHER -
Noordwest Ziekenhuisgroep
lead OTHER
Eligibility
- Min Age
- 0 Years
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-09-20
- Primary Completion
- 2025-12-01
- Completion
- 2025-12-01
Countries
- Netherlands
Study Locations
More Related Trials
-
Rapid Strep Testing in Children With Recent Streptococcal Pharyngitis
NCT03055728 ·Status: COMPLETED
-
Diagnostic Accuracy of Rapid Molecular Tests for Group A Streptococcal Pharyngitis Using Saliva Samples
NCT05521568 ·Status: COMPLETED
-
Long Term Follow-up of Patients With Group A Streptococcal Infection Originating From the Genital Tract
NCT00299663 ·Status: COMPLETED
-
The Effects of Antibiotic Exposure in Early Infancy on Vaccine Responses
NCT06079606 ·Status: ACTIVE_NOT_RECRUITING
-
The Relationship Between GBS Screening in Pregnant Women Insured in Maccabi Healthcare Services (MHS) and Early-onset Neonatal Disease in Israel
NCT04222907 ·Status: COMPLETED
-
Nasopharyngeal Bacterial Carriage and Antibiotic Resistance in Children With Sickle Cell Disease in Ile-De-France
NCT05197205 ·Status: UNKNOWN ·Phase: NA
-
Evaluation of the IND One Step Strep A Rapid Test vs. Culture
NCT01491776 ·Status: UNKNOWN
-
Development of a Serocorrelate of Protection Against Invasive Group B Streptococcus Disease
NCT04735419 ·Status: RECRUITING
-
Maternal, Neonatal and Infant Outcomes at Kawempe National Referral Hospital
NCT04653948 ·Status: ACTIVE_NOT_RECRUITING
-
SeroCovid<19: Covid-19 Seroconversion in Tertiary Pediatric Patients
NCT04615000 ·Status: COMPLETED
-
Pediatric Intensive Care Unit and Primary Immune Deficiency
NCT05629247 ·Status: COMPLETED ·Phase: NA
-
A Prospective Cohort Pilot Study of the Clinical and Molecular Epidemiology of Staphylococcus Aureus in Pregnant Women at the Time of Group B Streptococcal Screening in a Large Urban Medical Center in Chicago, IL USA
NCT00532324 ·Status: COMPLETED ·Phase: NA
-
Feasibility Study for Identifying Anti Capsular Antibody Protection Against Invasive Group B Streptococcus (GBS) Disease in Newborns of 0-6 Days Age (Early Onset Disease [EOD]) as Well as Among Infants of 7-90 Days Age (Late Onset Disease [LOD])
NCT01888471 ·Status: COMPLETED ·Phase: NA
-
Febrile Infants Swedish Study
NCT07134751 ·Status: RECRUITING
-
Rapid Blood Culture Identification Panel in Pediatric Patients in Guatemala
NCT05314816 ·Status: COMPLETED ·Phase: NA
-
Developing a Controlled Human Infection Model for Group B Streptococcus (CHIM_GBS)
NCT04059510 ·Status: UNKNOWN
-
Prevention of Diseases Induced by Chlamydia Trachomatis
NCT02904811 ·Status: COMPLETED ·Phase: NA
-
An Assessment of Rapid Streptococcal Tests in Community Clinics in Israel
NCT00535093 ·Status: COMPLETED ·Phase: NA
-
National Observatory of Mycoplasma Infections in Children Under 18 Ages in France
NCT06260371 ·Status: COMPLETED
-
Neonatal Sepsis and GBS Carriage Study
NCT00861055 ·Status: COMPLETED
-
Genetic Susceptibility to Severe Streptococcal Infections
NCT01911572 ·Status: UNKNOWN
-
Comparison of Two Rapid Antigen Detection Tests for the Detection of Group-A Streptococcal Pharyngitis in Children
NCT03099018 ·Status: COMPLETED
-
Paediatric Infections Point-Of-Care
NCT03900091 ·Status: COMPLETED
-
Serosurveillance Study of Maternally Derived Anti-GBS Antibody
NCT04549220 ·Status: ACTIVE_NOT_RECRUITING
-
Evaluation of Post Infectious Inflammatory Reaction (PIIR) Concerning Children After Streptococcus Pneumoniae, Streptococcus Pyogenes and Neisseria Meningococcus Invasive Infection
NCT04594785 ·Status: UNKNOWN