Invasive Group A Beta-Haemolytic Streptococcal DiseaseIGASINCT06297122
Severe Group A Streptococcus Infections in Paris, France, 2018-2023
An observational study of Invasive Group A Beta-Haemolytic Streptococcal Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Invasive Group A Beta-Haemolytic Streptococcal Disease
- What is being tested?
- Collection of data from the patient's medical file
- Type of treatment
- Injection or infusion
- How many people
- 269 participants
- Where
- 1 siteFrance
- Study dates
- 13 May 2024to 19 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
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- "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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Severe Group A Streptococcus Infections in Children During the COVID-19 Pandemic: an Interrupted Time-series Analysis in Paris, France, 2018-2023
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.
Read more
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.
Read the 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.
- Being tested
- Collection of data from the patient's medical file
- Keywords
- Group A Streptococcus (GAS) infection, Pediatric severe GAS infections, GAS infection incidence, COVID-19 pandemic, Time-series analysis
- Medical subject headings
- Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of data from the patient's medical fileOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Collection of data from the patient's medical file |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 years
Secondary outcomes (7)
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).
Measured: 6 years
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 %).
Measured: 6 years
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 %).
Measured: 6 years
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 %).
Measured: 6 years
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).
Measured: 6 years
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.
Measured: 6 years
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 %).
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start13 May 2024
- Primary completion19 Aug 2024
- Study completion19 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Invasive Group A Beta-Haemolytic Streptococcal DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 269 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Jérémie Cohen, Principal investigator, Assistance Publique - Hôpitaux de ParisAlix Flamant, M.D., Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06297122
- Sponsor's protocol ID
- APHP240002
- Acronym
- IGASI
- Status last verified
- Sep 2025
- First submitted
- 19 Feb 2024
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40440703
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Severe Group A Streptococcus Infections in Children During the COVID-19 Pandemic: an Interrupted Time-series Analysis in Paris, France, 2018-2023
- ClinicalTrials.gov ID
- NCT06297122
- Acronym / sponsor ID
- IGASI / APHP240002
- Keywords
- Group A Streptococcus (GAS) infection, Pediatric severe GAS infections, GAS infection incidence, COVID-19 pandemic, Time-series analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 269 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 13 May 2024 (actual)
- Primary completion
- 19 Aug 2024 (actual)
- Study completion
- 19 Aug 2024 (actual)
- First posted
- 7 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Collection of data from the patient's medical fileAll 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. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (10 listed)
- 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.
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of data from the patient's medical fileCollection 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. | Other | Patients |
Primary outcome
Monthly incidence of severe Group A Streptococcus (GAS) infections per 1000 pediatric hospital admissions
Time frame: 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).
7 secondary outcomes
Age of children age with group A Streptococcus (GAS) infections
Time frame: 6 years
Proportion of children needing surgical intervention for the management of GAS infection
Time frame: 6 years
Proportion of cases admitted in the PICU for GAS infection
Time frame: 6 years
Proportion of deaths from GAS infection
Time frame: 6 years
Hospital length of stay for the management of GAS infection
Time frame: 6 years
Distribution of infection type of GAS infection
Time frame: 6 years
Proportion of healthcare-associated infections during the management of GAS infection
Time frame: 6 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Results publication: PubMed 40440703Flamant 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jérémie Cohen principal investigator
Assistance Publique - Hôpitaux de Paris
Alix Flamant, M.D. study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Group A Beta-Haemolytic Streptococcal Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monthly incidence of severe Group A Streptococcus (GAS) infections per 1000 pediatric hospital admissions (time frame: 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06297122, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.