Invasive Group A Streptococcal Infection | NCT05788861

Studies
Invasive Group A Streptococcal Infection

NCT05788861

Sponsor

Association Clinique Thérapeutique Infantile du val de Marne

Status

Recruiting

Last Update Posted

Feb 8, 2024Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

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

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2022Actual

Primary Completion Date

Sep 1, 2026Estimated

Completion Date

Sep 1, 2026Estimated

First Submitted Date

Dec 22, 2022

First Submission Date that Met QC Criteria

Mar 16, 2023

First Posted Date

Mar 29, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 7, 2024

Last Update Posted Date

Feb 8, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

Opposition of the patient or his/her legal representative

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

17 Years

Standard Ages

Child

Study Population

Pediatrics patients with documented invasive infection due to Group A Streptococcus

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Levy Corinne	Contact	1 48 85 04 04	+33	corinne.levy@activ-france.fr
Bechet Stephane	Contact	1 48 85 96 68	+33	stephane.bechet@activ-france.fr

Overall Officials

Name	Affiliation	Role
Yves Gillet	hôpital Femme-Mère-Enfant, Bron	Principal Investigator
Camille Brehin	HOPITAUX MERE et ENFANTS CHU TOULOUSE	Principal Investigator
Lionel Berthomieu

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ACTIV	Recruiting	Créteil		94000	France

Condition Browse Module

MeSH Terms

ID	Term
D007239	Infections
D013180	Sprains and Strains

Ancestor Terms

ID	Term
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided