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NCT05788861 Clinical Trial

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
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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