Invasive Group A Streptococcal Infection

Recruiting

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

• Registration Number: NCT05788861
• Lead Sponsor: Association Clinique Thérapeutique Infantile du val de Marne

Brief Summary

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

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 Timeline

• Study Start: 2022-09-01
• Study First Submitted: 2022-12-22
• Study First Submitted QC: 2023-03-16
• Study First Posted: 2023-03-29
• Status Verified: 2024-01
• Last Update Submitted: 2024-02-07
• Last Update Posted: 2024-02-08
• Primary Completion: 2026-09-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complications	1 year	what are the complications due to severe infection
Treatments used in routine care unit	1 year	which treatments are used in routine care unit to treat the infection
Death	1 year	Death Outcome during hospitalisation
Treatments provided in intensive care unit	1 year	what treatments are used in intensive care unit to treat infection
Risk factors	1 year	description of underlying conditions
Hospitalisation	1 year	How long patient was hospitalised during this infection
Characterization of Group A Streptococcus strains	1 year	Characterization of Group A Streptococcus strains by the CNR

Trial Locations

Locations (1)

ACTIV; 🇫🇷 Créteil, France