Severe Group A Streptococcus Infections in Paris, France, 2018-2023

NCT06297122 | Completed

• 1 other identifier: APHP240002
• Study Type: observational
• Target: 269
• Locations: 1 country
• Sites: 1

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.

Conditions

Invasive Group A Beta-Haemolytic Streptococcal Disease

Keywords

Group A Streptococcus (GAS) infection; Pediatric severe GAS infections; GAS infection incidence; COVID-19 pandemic; Time-series analysis

Outcome Measures

Primary Outcomes (1)

• Monthly incidence of severe Group A Streptococcus (GAS) infections per 1000 pediatric hospital admissions

  The monthly incidence of severe group A streptococcal infections per 1000 pediatric hospital admissions. Two specific breakpoints in the data will be used: March 2020, marking the first lockdown, and March 2022, marking the point when mask-wearing in schools was no longer mandatory. This will allow to define four distinct periods for analysis: * January 2018 to March 2020 (pre-pandemic period), * April 2020 to March 2022 (early pandemic period), * April 2022 to September 2023 (late pandemic period), and * May 2023 to December 2023 (post pandemic period).

  6 years

Secondary Outcomes (7)

• Age of children age with group A Streptococcus (GAS) infections

  6 years

• Proportion of children needing surgical intervention for the management of GAS infection

  6 years

• Proportion of cases admitted in the PICU for GAS infection

  6 years

• Proportion of deaths from GAS infection

  6 years

• Hospital length of stay for the management of GAS infection

  6 years

Study Arms (1)

Patients

All consecutive children under the age of 18 years with community-acquired or healthcare-associated severe Group A Streptococcus (GAS) infections admitted to Necker hospital between January 1, 2018, and December 31, 2023. Among GAS infections, invasive and probable invasive GAS illnesses will be distinguish. "Invasive GAS" infection will be defined as: isolation by culture or polymerase chain reaction of GAS from a normally sterile site; or isolation of GAS from a sterile or non-sterile site accompanied by necrotizing fasciitis or streptococcal toxic shock syndrome. "Probable invasive" GAS will be defined as acute infections with GAS isolated from a non-sterile site, which includes sputum, otorhinolaryngology surgical specimens (mastoiditis, ethmoiditis, pharyngeal abscess) accompanied with one or more of the following severity criteria:intravenous antibiotics;surgery; and/or admission to the pediatric intensive care unit.

Other: Collection of data from the patient's medical file

Interventions

Collection of data from the patient's medical file OTHER

Collection of data from the patient's medical file (electronic health record). The identification of eligible cases will be conducted through an examination of the hospital's electronic microbiology database. Subsequently, the complete hospital record(s) of each patient will be used to extract a pre-defined set of variables required for data analysis.

Patients

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All consecutive children under the age of 18 years with community-acquired or healthcare-associated severe Group A Streptococcus (GAS) infections admitted to Necker-Enfants Malades hospital between January 1, 2018, and December 31, 2023.

You may qualify if:

• Children under the age of 18 years.
• Admitted to Necker-Enfants Malades hospital for community-acquired or healthcare-associated severe Group A Streptococcus (GAS) infections between January 1, 2018, and December 31, 2023.
• Severe GAS infections comprises "invasive" and "probable invasive" GAS illnesses.
• "Invasive" GAS infection will be defined as:
• isolation by culture or polymerase chain reaction (PCR) of GAS from a normally sterile site (e.g., blood, pleural fluid, cerebrospinal fluid, joint fluid, bone, bronchoalveolar lavage fluid); or
• isolation of GAS from a sterile or non-sterile site accompanied by necrotizing fasciitis or streptococcal toxic shock syndrome.
• "Probable invasive" GAS will be defined as acute infections with GAS isolated from a non-sterile site, which includes sputum, otorhinolaryngology surgical specimens (mastoiditis, ethmoiditis, pharyngeal abscess) accompanied with one or more of the following severity criteria:
• intravenous (IV) antibiotics;
• surgery; and/or
• admission to the PICU.

You may not qualify if:

• Non-severe GAS infection, such as acute otitis media with otorrhea, pharyngitis, scarlet fever, GAS skin carriage.
• GAS identified on minor/superficial skin lesions.
• Otolaryngology infections (e.g., parapharyngeal abscess) that do not require IV antibiotics, surgery, or PICU admission.
• Opposition to the use of routine data.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Necker-Enfants Malades

Paris, 75015, France

Location

Related Publications (1)

• Flamant A, Faury H, Luscan R, Couloigner V, Pouletty M, Bustarret O, Chappuy H, Gaume M, Drummond D, Pinhas Y, Toubiana J, Ferroni A, Cohen JF. Severe Group A Streptococcus Infections in Children During and After the COVID-19 Pandemic: An Interrupted Time-series Analysis in Paris, France, 2018-2023. Pediatr Infect Dis J. 2025 Oct 1;44(10):973-978. doi: 10.1097/INF.0000000000004872. Epub 2025 May 28.

  PMID: 40440703 BACKGROUND

MeSH Terms

Conditions

Infections; COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jérémie Cohen

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Alix Flamant, M.D.

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: March 7, 2024
• Study Start: May 13, 2024
• Primary Completion: August 19, 2024
• Study Completion: August 19, 2024
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)