Clinical trial NCT02899702: Effectiveness of Intravenous Immunoglobulins (IVIG) in Toxic Shock Syndromes in Children
Official title: Effectiveness of Intravenous Immunoglobulins (IVIG) in Toxic Shock Syndromes in Children: a Multicentre European Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Staphylococcal Infection
Streptococcal Infection
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-09-14
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: IGHN2 is an international, multicenter, double blind, randomized controlled trial aimed at assessing the efficacy on organ dysfunctions of Intravenous Immunoglobulins (IVIG) treatment in the acute phase of streptococcal or staphylococcal toxic shock syndrome in children.


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

Primary outcomes:
measure: organ dysfunctions
timeFrame: between day of admission and day 3
Secondary outcomes:
measure: global mortality
timeFrame: 1 year
measure: disability assessed by the Pediatric Overall Performance Category (POPC) score
timeFrame: one year after recruitment
measure: impairment assessed by the Vineland Adaptive Behavior Scale 2 (VABS II)
timeFrame: one year after recruitment
measure: organ dysfunctions assessed by the PELOD-2 score
timeFrame: over the first 5 days in Paediatric Intensive Care Unit (PICU)
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Femme Mère Enfant
Study officials:
affiliation: Hospices Civils de Lyon
name: Etienne JAVOUHEY
role: PRINCIPAL_INVESTIGATOR
References: