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Recruiting

NCT Number: NCT05788861

Invasive Group A Streptococcal Infection

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

Recruiting

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Key information

Conditions

Sepsis Due to Streptococcus, Group A Infections Medical Care Medical Complications Outcome, Fatal Risk Factors Severe Infection Sprains and Strains Strain Therapy Virulence Factors Wounds and Injuries

Age range

1 day–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Hospitalisation

    Time frame: 1 year

    How long patient was hospitalised during this infection

  2. Treatments provided in intensive care unit

    Time frame: 1 year

    what treatments are used in intensive care unit to treat infection

  3. Complications

    Time frame: 1 year

    what are the complications due to severe infection

  4. Treatments used in routine care unit

    Time frame: 1 year

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

  5. Risk factors

    Time frame: 1 year

    description of underlying conditions

  6. Characterization of Group A Streptococcus strains

    Time frame: 1 year

    Characterization of Group A Streptococcus strains by the CNR

  7. Death

    Time frame: 1 year

    Death Outcome during hospitalisation

Study contacts

Contact information is provided by the study sponsor or research team.

Bechet Stephane

CONTACT

[email protected]

1 48 85 96 68 ext. +33

Levy Corinne

CONTACT

[email protected]

1 48 85 04 04 ext. +33

Sponsors and collaborators

Lead sponsor

Association Clinique Thérapeutique Infantile du val de Marne

Other

Registry information

Official study title

French Pediatric Nationwide Observatory of Invasive Group A Streptococcal Infection (in Childen for 0 to 18 Ages)

Acronym: ISAI

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 29, 2023
Registry last updated
Feb 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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