Sepsis Due to Streptococcus, Group AISAINCT05788861
Invasive Group A Streptococcal Infection
An observational study of Sepsis Due to Streptococcus, Group A and Risk Factors, run by Association Clinique Thérapeutique Infantile du val de Marne at 1 site in France.
Trial summary
This study is observational, retrospective and prospective study in pediatric patients hospitalized with invasive streptococcal A infection Read more about this study
- Who is it for?
- Ages 1 day to 17 years
- Conditions the study is for
- Sepsis Due to Streptococcus, Group A, Risk Factors, Severe Infection
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2022to 1 Sep 2026
- 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 1 day to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatrics patients with documented invasive infection due to Group A Streptococcus
Who may be able to join
- Age<18 years
- Documented invasive Group A Streptococcus infection (identification of GAS in a normally sterile site or from another site in case of toxin shock or necrotizing dermo-hypodermatitis)
Who cannot join
- Opposition of the patient or his/her legal representative
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
ACTIV
Créteil, 94000
Corinne Levy, MD, 0033148850404, corinne.levy@activ-france.fr
Stéphane Béchet, MSc, 0033148850404, stephane.bechet@activ-france.fr
About this study
Official title: French Pediatric Nationwide Observatory of Invasive Group A Streptococcal Infection (in Childen for 0 to 18 Ages)
This study is observational, retrospective and prospective study in pediatric patients hospitalized with invasive streptococcal A infection
Read the detailed description
The main of this study is to identify and record cases of invasive and severe infections due to Streptococcus pyogenes. In order to evaluate the incidence of severe forms of disease and the possible contributing factors, and to optimize their management.
Admitted patients to intensive care or critical care units in reported via Santé Publique France may also be included in this study.
Secondly, epidemiological, clinical, bacteriological data of all severe or not cases, of group A Streptococcal infections will be compiled to describe their characteristics, and try to explain this recrudescence as well as possible.
- Conditions
- Sepsis Due to Streptococcus, Group A, Risk Factors, Severe Infection, Medical Care, Medical Complications, Outcome, Fatal
- Medical subject headings
- Infections, Sprains and Strains
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalisation
How long patient was hospitalised during this infection
Measured: 1 year
Treatments provided in intensive care unit
what treatments are used in intensive care unit to treat infection
Measured: 1 year
Complications
what are the complications due to severe infection
Measured: 1 year
Treatments used in routine care unit
which treatments are used in routine care unit to treat the infection
Measured: 1 year
Risk factors
description of underlying conditions
Measured: 1 year
Characterization of Group A Streptococcus strains
Characterization of Group A Streptococcus strains by the CNR
Measured: 1 year
Death
Death Outcome during hospitalisation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start1 Sep 2022
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sepsis Due to Streptococcus, Group AStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association Clinique Thérapeutique Infantile du val de Marne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yves Gillet, Principal investigator, hôpital Femme-Mère-Enfant, BronCamille Brehin, Principal investigator, HOPITAUX MERE et ENFANTS CHU TOULOUSELionel Berthomieu, Principal investigator, University Hospital, ToulouseCorinne Levy, Study director, Association Clinique Thérapeutique Infantile du val de Marne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05788861
- Sponsor's protocol ID
- ISAI
- Acronym
- ISAI
- Status last verified
- Jan 2024
- First submitted
- 22 Dec 2022
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French Pediatric Nationwide Observatory of Invasive Group A Streptococcal Infection (in Childen for 0 to 18 Ages)
- ClinicalTrials.gov ID
- NCT05788861
- Acronym / sponsor ID
- ISAI / ISAI
- Conditions
- Sepsis Due to Streptococcus, Group A, Risk Factors, Severe Infection, Medical Care, Medical Complications, Outcome, Fatal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Association Clinique Thérapeutique Infantile du val de MarneUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 29 Mar 2023 (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.
This study is observational, retrospective and prospective study in pediatric patients hospitalized with invasive streptococcal A infection
Detailed description
The main of this study is to identify and record cases of invasive and severe infections due to Streptococcus pyogenes. In order to evaluate the incidence of severe forms of disease and the possible contributing factors, and to optimize their management.
Admitted patients to intensive care or critical care units in reported via Santé Publique France may also be included in this study.
Secondly, epidemiological, clinical, bacteriological data of all severe or not cases, of group A Streptococcal infections will be compiled to describe their characteristics, and try to explain this recrudescence as well as possible.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatrics patients with documented invasive infection due to Group A Streptococcus
Key inclusion criteria (2 listed)
- Age<18 years
- Documented invasive Group A Streptococcus infection (identification of GAS in a normally sterile site or from another site in case of toxin shock or necrotizing dermo-hypodermatitis)
Key exclusion criteria (1 listed)
- Opposition of the patient or his/her legal representative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hospitalisation
Time frame: 1 year
How long patient was hospitalised during this infection
Treatments provided in intensive care unit
Time frame: 1 year
what treatments are used in intensive care unit to treat infection
Complications
Time frame: 1 year
what are the complications due to severe infection
Treatments used in routine care unit
Time frame: 1 year
which treatments are used in routine care unit to treat the infection
Risk factors
Time frame: 1 year
description of underlying conditions
Characterization of Group A Streptococcus strains
Time frame: 1 year
Characterization of Group A Streptococcus strains by the CNR
Death
Time frame: 1 year
Death Outcome during hospitalisation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
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.
Yves Gillet principal investigator
hôpital Femme-Mère-Enfant, Bron
Camille Brehin principal investigator
HOPITAUX MERE et ENFANTS CHU TOULOUSE
Lionel Berthomieu principal investigator
University Hospital, Toulouse
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 Sepsis Due to Streptococcus, Group A and Risk Factors, run by Association Clinique Thérapeutique Infantile du val de Marne 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 8 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Levy Corinne (1 48 85 04 04 ext. +33, corinne.levy@activ-france.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospitalisation (time frame: 1 year). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2024.