Invasive Group A Streptococcal Infection

Risk Factors Clinical Trial

— ISAI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05788861
• Other study ID #: ISAI
• Status: Recruiting
• Start date: September 1, 2022
• Est. completion date: September 1, 2026

Study information

• Verified date: January 2024
• Source: Association Clinique Thérapeutique Infantile du val de Marne
• Contact: Levy Corinne
• Phone: 1 48 85 04 04
• Email: corinne.levy[@]activ-france.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 1, 2026
• Est. primary completion date: September 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Medical Care
• Outcome, Fatal
• Risk Factors
• Severe Infection
• Strain
• Streptococcal Infections
• Therapy
• Virulence Factors

Locations

Country	Name	City	State
France	ACTIV	Créteil

Sponsors (1)

Lead Sponsor	Collaborator
Association Clinique Thérapeutique Infantile du val de Marne

Country where clinical trial is conducted

France, 

Outcome

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