Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT02010294
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 1 month to \<15 years at the time of inclusion
* Group 1 : Children hospitalized for invasive GAS infection
* Subgroup 1A ( N = 75 ): Children with invasive infection without known risk factor .
* Subgroup 1B (N = 75) : Children with invasive infection with known risk factor .
GAS Invasive infections are defined by:
a) Proved infection : Bacteriological isolation of S. pyogenes from a liquid or a normally sterile site, except from a blister of a simple erysipelas, without necrosis . This is sometimes associated with a shock with multiorgan failure (streptococcal toxic shock syndrome ( STSS )) b ) Probable infection :
1. . Bacteriological isolation of S. pyogenes from a normally non-sterile site ( eg skin, upper respiratory tract ) associated with extensive soft tissue necrosis
2. . Bacteriological isolation of S. pyogenes a site or a biological sample usually non-sterile ( eg skin , upper respiratory tract ) associated with a evocative shock syndrome STSS and no other cause found .
Contributing factors for invasive infection are defined by:
cutaneous effraction (wounds , burn , chicken pox ), the use of corticosteroids or other treatment, immunosuppressive and recent surgery
• Group 2: non-invasive infection such as pharyngitis , tonsillitis, proctitis or skin infection diagnosed by a positive test for rapid diagnosis of GAS performed at the site of infection with a positive GAS culture.
Exclusion Criteria:
* Group 1: Children with a known immune deficiency unrelated to the risk factors described above.
* Group 2: Children with a known immune deficiency.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Month
Maximum Age:
15 Years
Study:
NCT02010294
Study Brief:
Protocol Section:
NCT02010294