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RecruitingNCT05788861ISAIUpdated Feb 8, 2024

Invasive Group A Streptococcal Infection

An observational study in Sepsis Due to Streptococcus, Group A, Risk Factors and Severe Infection, sponsored by Association Clinique Thérapeutique Infantile du val de Marne. Recruiting at 1 site in France. Open to participants aged 1 Day to 17 Years. Per ClinicalTrials.gov, last updated 2024-02-08.

Sponsored by Association Clinique Thérapeutique Infantile du val de Marne · Observational

From the registry’s dates

  • Started Sep 2022; still recruiting 4 years 1 month later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
100
Ages
1 Day to 17 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Sepsis Due to Streptococcus, Group A
  • Risk Factors
  • Severe Infection
  • Medical Care
  • Medical Complications
  • Outcome, Fatal
  • Therapy
  • Strain
  • Virulence Factors
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's planned enrollment of 100 is below the median of 240 across 2,136 observational studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Association Clinique Thérapeutique Infantile du val de Marne is the lead sponsor of 15 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Pediatrics patients with documented invasive infection due to Group A Streptococcus

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • Opposition of the patient or his/her legal representative
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Hospitalisation

    How long patient was hospitalised during this infection

    Time frame: 1 year

  2. Treatments provided in intensive care unit

    what treatments are used in intensive care unit to treat infection

    Time frame: 1 year

  3. Complications

    what are the complications due to severe infection

    Time frame: 1 year

  4. Treatments used in routine care unit

    which treatments are used in routine care unit to treat the infection

    Time frame: 1 year

  5. Risk factors

    description of underlying conditions

    Time frame: 1 year

  6. Characterization of Group A Streptococcus strains

    Characterization of Group A Streptococcus strains by the CNR

    Time frame: 1 year

  7. Death

    Death Outcome during hospitalisation

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05788861
Lead sponsor
Association Clinique Thérapeutique Infantile du val de Marne
Responsible party
Sponsor
First posted
Mar 29, 2023
Start date
Sep 1, 2022
Primary completion
Sep 1, 2026 (estimated)
Completion
Sep 1, 2026 (estimated)
Last update
Feb 8, 2024

Study contacts

Levy Corinne
Contact
corinne.levy@activ-france.fr
1 48 85 04 04 ext. +33
Bechet Stephane
Contact
stephane.bechet@activ-france.fr
1 48 85 96 68 ext. +33
Yves Gillet
principal investigator · hôpital Femme-Mère-Enfant, Bron
Camille Brehin
principal investigator · HOPITAUX MERE et ENFANTS CHU TOULOUSE
Lionel Berthomieu
principal investigator · CHU Toulouse
Corinne Levy
study director · Association Clinique Thérapeutique Infantile du val de Marne

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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