Status:
COMPLETED
Efficacy of IntraVenous ImmunoGlobulins in Toxic Shock Syndromes: a Paediatric Pilot Study
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Toxic Shock Syndrome
Eligibility:
All Genders
1-17 years
Phase:
PHASE2
Brief Summary
Staphylococcus aureus and Streptococcus pyogenes produce many virulence factors. Some of them are responsible for severe infections in humans. Superantigen toxins synthesized by S. aureus or by S. pyo...
Eligibility Criteria
Inclusion
- 1 month \<Age \< 18 years
- Admitted to PICU, with a strong suspicion of staphylococcal or streptococcal infection (at least one of the following criteria):
- Diagnostic of TSS according to CDC (Centre for Disease Control) criteria or Group A streptococcus necrotizing fasciitis (positive streptest) or Varicella with infected lesions and erythroderma or positive streptest or Erythroderma in menstrual period or Pleuropneumopathy with erythroderma or positive streptest in pleural fluid or Erythroderma and biological fluid positive to type A streptococcus ou staphylococcus (articular, pericardial, bronchopulmonar, pharynx…)
- with shock resistant to fluid resuscitation defined as the presence, despite 40 ml/kg of fluid volume in 1 hour, of: hypotension (\<5th percentile) or systolic arterial pressure \< 2 SD for age or need for vasoactive drugs in order to maintain AP at a normal level (dopamine \> 5µg/kg/min or dobutamine, adrenaline, noradrenaline, milrinone whatever the dose) or 2 signs of hypo perfusion among: metabolic acidosis with a base deficit \> 5 lactate x 2 laboratory normal value diuresis \< 0,5 ml/kg/h capillary refill time \> 5 sec difference skin/central temperature \> 3°C
- Consent to participation
Exclusion
- First signs of shock appeared more than 24h ago
- Known hypersensitivity to one of the components (study treatment or placebo)
- 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
Key Trial Info
Start Date :
January 8 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 19 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02219165
Start Date
January 8 2015
End Date
April 19 2019
Last Update
September 4 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hôpital Femme Mère Enfant
Bron, France, 69677