Invasive Group A Streptococcal Infection (ISAI)

French Pediatric Nationwide Observatory of Invasive Group A Streptococcal Infection (in Childen for 0 to 18 Ages)

This study is observational, retrospective and prospective study in pediatric patients hospitalized with invasive streptococcal A infection

Study Overview

• Status: Recruiting
• Conditions: Risk Factors; Outcome, Fatal; Therapy; Severe Infection; Strain; Virulence Factors; Medical Care; Sepsis Due to Streptococcus, Group A; Medical Complications

Detailed Description

The main of this study is to identify and record cases of invasive and severe infections due to Streptococcus pyogenes. In order to evaluate the incidence of severe forms of disease and the possible contributing factors, and to optimize their management.

Admitted patients to intensive care or critical care units in reported via Santé Publique France may also be included in this study.

Secondly, epidemiological, clinical, bacteriological data of all severe or not cases, of group A Streptococcal infections will be compiled to describe their characteristics, and try to explain this recrudescence as well as possible.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Levy Corinne; Phone Number: +33 1 48 85 04 04; Email: corinne.levy@activ-france.fr
• Study Contact Backup: Name: Bechet Stephane; Phone Number: +33 1 48 85 96 68; Email: stephane.bechet@activ-france.fr

Study Locations

• France
  • Créteil, France, 94000
    • Recruiting
    • ACTIV
    • Contact: Corinne Levy, MD; Phone Number: 0033148850404; Email: corinne.levy@activ-france.fr
    • Contact: Stéphane Béchet, MSc; Phone Number: 0033148850404; Email: stephane.bechet@activ-france.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 17 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Pediatrics patients with documented invasive infection due to Group A Streptococcus

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• Opposition of the patient or his/her legal representative

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Association Clinique Thérapeutique Infantile du val de Marne
• Investigators: Principal Investigator: Yves Gillet, hôpital Femme-Mère-Enfant, Bron; Principal Investigator: Camille Brehin, HOPITAUX MERE et ENFANTS CHU TOULOUSE; Principal Investigator: Lionel Berthomieu, CHU Toulouse; Study Director: Corinne Levy, Association Clinique Thérapeutique Infantile du val de Marne

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: December 22, 2022
• First Submitted That Met QC Criteria: March 16, 2023
• First Posted (Actual): March 29, 2023

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Infections; Communicable Diseases; Streptococcal Infections
• Other Study ID Numbers: ISAI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No