Severe Group a Streptococcus Infections in Paris, France, 2018-2023
- Conditions
- Invasive Group a Beta-Haemolytic Streptococcal Disease
- Interventions
- Other: Collection of data from the patient's medical file
- Registration Number
- NCT06297122
- Lead Sponsor
- Assistance Publique - H么pitaux de Paris
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 269
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients Collection of data from the patient's medical file 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.
- Primary Outcome Measures
Name Time Method Monthly incidence of severe Group A Streptococcus (GAS) infections per 1000 pediatric hospital admissions 6 years 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).
- Secondary Outcome Measures
Name Time Method Proportion of cases admitted in the PICU for GAS infection 6 years 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 %).
Hospital length of stay for the management of GAS infection 6 years 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).
Distribution of infection type of GAS infection 6 years 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.
Age of children age with group A Streptococcus (GAS) infections 6 years Description of possible changes in characteristics of severe Group A Streptococcus (GAS) infections between the defined periods, in terms of children age (in years).
Proportion of children needing surgical intervention for the management of GAS infection 6 years 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 %).
Proportion of deaths from GAS infection 6 years Description of possible changes in characteristics of severe Group A Streptococcus (GAS) infections between the defined periods, in terms of proportion of deaths (in %).
Proportion of healthcare-associated infections during the management of GAS infection 6 years 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 %).
Trial Locations
- Locations (1)
H么pital Necker-Enfants Malades
馃嚝馃嚪Paris, France