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 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT02899702
Eligibility Criteria:
Inclusion Criteria:
* Child/adolescent: 1 month \< Age \< 17 year-old,
* admitted to PICU with a strong suspicion of staphylococcal or streptococcal infection; at least one following criterion, with at least one following criteria:
1. Toxic Shock Syndrom as defined by Centre for Disease Control criteria
2. or group A Streptococcus necrotizing fasciitis (positive streptest)
3. or varicella with infected lesions and rash or positive streptest
4. or erythrodermic rash in menstrual period
5. or pleuropneumonia with erythrodermic rash or positive streptest in pleural fluid
6. or erythrodermic rash and biological fluid positive to streptococcus A or staphylococcus (articular, pericardial, bronchopulmonary, pharynx)
* With shock resistant to fluid resuscitation, defined as existence, despite 40 ml/kg of fluid bolus within 1 hour, of:
1. hypotension (\< 5th percentile)
2. or systolic blood pressure \< 2 SD regarding age
3. or need for vasoactive drugs in order to maintain blood pressure at a normal level (dopamine \> 5µg/kg/min or dobutamine, adrenaline, noradrenaline, milrinone whatever the dose)
4. or 2 signs of hypo perfusion among:
1. metabolic acidosis with base deficit \> 5
2. lactate x 2 normal laboratory value
3. diuresis \< 0,5 ml/kg/h
4. capillary refill time \> 5 sec
5. Skin/central temperature difference \> 3°C
* With informed consent signed by at least one parent before any procedures or treatments related to the study.
Exclusion Criteria:
* First signs of shock appeared more than 24h ago
* Known hypersensitivity to one of the components (study treatment or placebo , see below)
* Hypersensitivity to homologous immunoglobulins, specifically in very rare cases of Ig A deficit, when the patient has anti-IgA antibodies
* Known hyperprolinemia
* Immunodeficiency (acquired or not),
* Immunosuppressive drugs
* No health cover
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Month
Maximum Age:
17 Years
Study:
NCT02899702
Study Brief:
Protocol Section:
NCT02899702