Invasive Group A Streptococcal Infection
ISAI
French Pediatric Nationwide Observatory of Invasive Group A Streptococcal Infection (in Childen for 0 to 18 Ages)
1 other identifier
observational
100
1 country
1
Brief Summary
This study is observational, retrospective and prospective study in pediatric patients hospitalized with invasive streptococcal A infection
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2022
CompletedFirst Submitted
Initial submission to the registry
December 22, 2022
CompletedFirst Posted
Study publicly available on registry
March 29, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
February 8, 2024
January 1, 2024
4 years
December 22, 2022
February 7, 2024
Conditions
Outcome Measures
Primary Outcomes (7)
Hospitalisation
How long patient was hospitalised during this infection
1 year
Treatments provided in intensive care unit
what treatments are used in intensive care unit to treat infection
1 year
Complications
what are the complications due to severe infection
1 year
Treatments used in routine care unit
which treatments are used in routine care unit to treat the infection
1 year
Risk factors
description of underlying conditions
1 year
Characterization of Group A Streptococcus strains
Characterization of Group A Streptococcus strains by the CNR
1 year
Death
Death Outcome during hospitalisation
1 year
Eligibility Criteria
Pediatrics patients with documented invasive infection due to Group A Streptococcus
You may qualify if:
- Age\<18 years
- Documented invasive Group A Streptococcus infection (identification of GAS in a normally sterile site or from another site in case of toxin shock or necrotizing dermo-hypodermatitis)
You may not qualify if:
- Opposition of the patient or his/her legal representative
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ACTIV
Créteil, 94000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yves Gillet
hôpital Femme-Mère-Enfant, Bron
- PRINCIPAL INVESTIGATOR
Camille Brehin
HOPITAUX MERE et ENFANTS CHU TOULOUSE
- PRINCIPAL INVESTIGATOR
Lionel Berthomieu
University Hospital, Toulouse
- STUDY DIRECTOR
Corinne Levy
Association Clinique Thérapeutique Infantile du val de Marne
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2022
First Posted
March 29, 2023
Study Start
September 1, 2022
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
February 8, 2024
Record last verified: 2024-01