NCT05788861

Brief Summary

This study is observational, retrospective and prospective study in pediatric patients hospitalized with invasive streptococcal A infection

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
4mo left

Started Sep 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Sep 2022Sep 2026

Study Start

First participant enrolled

September 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 29, 2023

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

February 8, 2024

Status Verified

January 1, 2024

Enrollment Period

4 years

First QC Date

December 22, 2022

Last Update Submit

February 7, 2024

Conditions

Outcome Measures

Primary Outcomes (7)

  • Hospitalisation

    How long patient was hospitalised during this infection

    1 year

  • Treatments provided in intensive care unit

    what treatments are used in intensive care unit to treat infection

    1 year

  • Complications

    what are the complications due to severe infection

    1 year

  • Treatments used in routine care unit

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

    1 year

  • Risk factors

    description of underlying conditions

    1 year

  • Characterization of Group A Streptococcus strains

    Characterization of Group A Streptococcus strains by the CNR

    1 year

  • Death

    Death Outcome during hospitalisation

    1 year

Eligibility Criteria

Age1 Day - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Pediatrics patients with documented invasive infection due to Group A Streptococcus

You may qualify if:

  • 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)

You may not qualify if:

  • Opposition of the patient or his/her legal representative

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ACTIV

Créteil, 94000, France

RECRUITING

MeSH Terms

Conditions

InfectionsSprains and Strains

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Yves Gillet

    hôpital Femme-Mère-Enfant, Bron

    PRINCIPAL INVESTIGATOR
  • Camille Brehin

    HOPITAUX MERE et ENFANTS CHU TOULOUSE

    PRINCIPAL INVESTIGATOR
  • Lionel Berthomieu

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR
  • Corinne Levy

    Association Clinique Thérapeutique Infantile du val de Marne

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2022

First Posted

March 29, 2023

Study Start

September 1, 2022

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

February 8, 2024

Record last verified: 2024-01

Locations