Viewing Study NCT06297122



Ignite Creation Date: 2024-05-06 @ 8:12 PM
Last Modification Date: 2024-10-26 @ 3:23 PM
Study NCT ID: NCT06297122
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-03-12
First Post: 2024-02-19

Brief Title: Severe Group A Streptococcus Infections in Paris France 2018-2023
Sponsor: Assistance Publique - Hôpitaux de Paris
Organization: Assistance Publique - Hôpitaux de Paris

Study Overview

Official Title: Severe Group A Streptococcus Infections in Children During the COVID-19 Pandemic an Interrupted Time-series Analysis in Paris France 2018-2023
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: IGASI
Brief Summary: Streptococcus pyogenes commonly referred to as Group A Streptococcus GAS has the ability to induce a diverse range of illnesses

In several European countries and the United States a notable surge in invasive GAS iGAS infections has been documented since mid-2022 This sharp increase contrasts with the gradual rise in iGAS incidence observed among children over the past three decades As demonstrated for several viral infections the recent upturn in iGAS infections is potentially linked to the relaxation of mitigation measures implemented during the COVID-19 pandemic such as face mask usage and school closures

Since November 2022 concerns have been raised by French public health authorities regarding the rise in levels of iGAS infections and an unexpected increase in pediatric severe GAS infections was reported in a French single-center study However this study ended in December 2022 and could only explore short-term trends The Necker - Enfants malades Hospital in Paris France represents an excellent opportunity to examine the impact of the COVID-19 pandemic and the associated non-pharmaceutical interventions on the incidence of severe GAS infections during and after the pandemic

This study aims to investigate trends of severe GAS infection incidence in children in the Paris area over the course of the COVID-19 pandemic
Detailed Description: Streptococcus pyogenes commonly referred to as Group A Streptococcus GAS has the ability to induce a diverse range of illnesses In primary care acute pharyngitis commonly known as strep throat is the predominant form of GAS infection Other commonly encountered non-invasive GAS infections encompass impetigo scarlet fever perianal infections and paronychia GAS may also cause rarer yet severe conditions such as streptococcal toxic shock syndrome pneumonia with pleural empyema and septic shock most severe GAS infections can even be life-threatening

In several European countries and the United States a notable surge in invasive GAS iGAS infections has been documented since mid-2022 This sharp increase contrasts with the gradual rise in iGAS incidence observed among children over the past three decades As demonstrated for several viral infections the recent upturn in iGAS infections is potentially linked to the relaxation of mitigation measures implemented during the COVID-19 pandemic such as face mask usage and school closures Non-pharmaceutical interventions and behavioral changes during the COVID-19 pandemic modified the spread of SARS-CoV-2 and several respiratory pathogens including GAS Reduced exposure to endemic infectious agents may have created an immunity gap leading to unexpected epidemics of viral and bacterial infections after non-pharmaceutical interventions were relaxed

Since November 2022 concerns have been raised by French public health authorities regarding the rise in levels of iGAS infections and an unexpected increase in pediatric severe GAS infections was reported in a French single-center study However this study ended in December 2022 and could only explore short-term trends The Necker - Enfants malades Hospital in Paris France represents an excellent opportunity to examine the impact of the COVID-19 pandemic and the associated non-pharmaceutical interventions on the incidence of severe GAS infections during and after the pandemic This tertiary care university hospital is located in a densely populated region and has various specialized departments involved in the management of severe infections including pediatric intensive care units PICU orthopedics pulmonology otolaryngology dermatology infectious diseases and microbiology

This study aims to investigate trends of severe GAS infection incidence in children in the Paris area over the course of the COVID-19 pandemic

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None