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

Invasive Group A Beta-Haemolytic Streptococcal Disease Clinical Trial

— IGASI  

Official title:

Severe Group A Streptococcus Infections in Children During the COVID-19 Pandemic: an Interrupted Time-series Analysis in Paris, France, 2018-2023

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06297122
• Other study ID #: APHP240002
• Status: Not yet recruiting
• Start date: March 2024
• Est. completion date: June 2024

Study information

• Verified date: February 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Jérémie Cohen, M.D., PhD
• Phone: 1 44 49 48 72
• Email: jeremie.cohen2[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Infections
• Invasive Group A Beta-Haemolytic Streptococcal Disease
• Streptococcal Infections

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Necker-Enfants Malades	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Age of children age with group A Streptococcus (GAS) infections	Description of possible changes in characteristics of severe Group A Streptococcus (GAS) infections between the defined periods, in terms of children age (in years).	6 years
Secondary	Proportion of children needing surgical intervention for the management of GAS infection	Description of possible changes in characteristics of severe Group A Streptococcus (GAS) infections between the defined periods, in terms of proportion of children needing surgical intervention for the management of GAS infection (in %).	6 years
Secondary	Proportion of cases admitted in the PICU for GAS infection	Description of possible changes in characteristics of severe Group A Streptococcus (GAS) infections between the defined periods, in terms of proportion of cases admitted in the PICU (in %).	6 years
Secondary	Proportion of deaths from GAS infection	Description of possible changes in characteristics of severe Group A Streptococcus (GAS) infections between the defined periods, in terms of proportion of deaths (in %).	6 years
Secondary	Hospital length of stay for the management of GAS infection	Description of possible changes in characteristics of severe Group A Streptococcus (GAS) infections between the defined periods, in terms o fhospital length of stay (in days).	6 years
Secondary	Distribution of infection type of GAS infection	Description of possible changes in characteristics of severe Group A Streptococcus (GAS) infections between the defined periods, in terms of distribution of infection type (in %). For example arthritis, empyema, pharyngeal abscess, isolated bacteremia. In the event of multiple diagnoses, the most serious will be kept.	6 years
Secondary	Proportion of healthcare-associated infections during the management of GAS infection	Description of possible changes in characteristics of severe Group A Streptococcus (GAS) infections between the defined periods, in terms of proportion of healthcare-associated infections (in %).	6 years