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Effectiveness of Intravenous Immunoglobulins (IVIG) in Toxic Shock Syndromes in Children (IGHN2)

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ClinicalTrials.gov Identifier: NCT02899702
Recruitment Status : Not yet recruiting
First Posted : September 14, 2016
Last Update Posted : February 26, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.

Condition or disease Intervention/treatment Phase
Staphylococcal Infection Streptococcal Infection Drug: PRIVIGEN (CSL Behring) Drug: Albumin Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Intravenous Immunoglobulins (IVIG) in Toxic Shock Syndromes in Children: a Multicentre European Randomized Controlled Trial
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Experimental: IVIG
PRIVIGEN (CSL Behring) NORMAL HUMAN IMMUNOGLOBULINS L-PROLINE, Water for injection
Drug: PRIVIGEN (CSL Behring)

Single administration of intravenous immunoglobulin solution Privigen® (CSL Behring AG, Bern, Switzerland) at a dose of 2g / kg. IGIV 2g/kg within 12 hours following PICU admission (or outbreak of first shock signs).

The treatment of toxic shock will be standardized. It consists of antibiotics: Amoxicillin-clavulanate and clindamycin (or Rifampicin, Rifadine® if allergic). Antibiotics are not considered as experimental treatments for this study. All treatments essential for the treatment of acute condition will be allowed and are not considered as experimental treatments for this study.


Placebo Comparator: control

Single administration of Albumin 4% diluted albumin (LFB), within 12 hours following PICU admission (or outbreak of first shock signs). Isovolume - so dose of 0.8 g/kg We chose as placebo albumin diluted to 4% because this solution has the advantage of having a comparable osmolality.

The treatment of toxic shock will be standardized. It consists of antibiotics: Amoxicillin-clavulanate and clindamycin (or Rifampicin, Rifadine® if allergic). Antibiotics are not considered as experimental treatments for this study. All treatments essential for the treatment of acute condition will be allowed and are not considered as experimental treatments for this study.

Drug: Albumin

4%(LFB) ALBUMIN Single administration of human Albumin 4% diluted albumin (VIALEBEX® LFB), within 12 hours following PICU admission (or outbreak of first shock signs). Isovolume - so dose of 0.8 g/kg (4gG, 100 ML, Sodium chloride 0.61 G / 100ML Water for injections QSP 100 ML Sodium caprylate 0.3 G / 100ML) We chose as placebo albumin diluted to 4% because this solution has the advantage of having a comparable osmolality.

The treatment of toxic shock will be standardized. It consists of antibiotics: Amoxicillin-clavulanate and clindamycin (or Rifampicin, Rifadine® if allergic). Antibiotics are not considered as experimental treatments for this study. All treatments essential for the treatment of acute condition will be allowed and are not considered as experimental treatments for this study.





Primary Outcome Measures :
  1. organ dysfunctions [ Time Frame: between day of admission and day 3 ]
    Average variation in Pediatric Logistic Organ Dysfunction 2 ( PELOD-2) score compared between the IVIG treatment arm and the placebo arm.


Secondary Outcome Measures :
  1. global mortality [ Time Frame: 1 year ]
  2. disability assessed by the Pediatric Overall Performance Category (POPC) score [ Time Frame: one year after recruitment ]
  3. impairment assessed by the Vineland Adaptive Behavior Scale 2 (VABS II) [ Time Frame: one year after recruitment ]
  4. organ dysfunctions assessed by the PELOD-2 score [ Time Frame: over the first 5 days in Paediatric Intensive Care Unit (PICU) ]


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Ages Eligible for Study:   1 Month to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02899702


Contacts
Contact: Etienne JAVOUHEY 427 856 156 ext +33 etienne.javouhey@chu-lyon.fr
Contact: Behrouz Kassaï 472 357 231 ext +33 behrouz.kassai-koupai@chu-lyon.fr

Locations
France
Hôpital Femme Mère Enfant Not yet recruiting
Bron, France
Contact: Etienne Javouhey         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Etienne JAVOUHEY Hospices Civils de Lyon

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02899702     History of Changes
Other Study ID Numbers: 69HCL16_0079
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Infection
Communicable Diseases
Staphylococcal Infections
Streptococcal Infections
Shock
Shock, Septic
Gram-Positive Bacterial Infections
Bacterial Infections
Pathologic Processes
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Anti-Bacterial Agents
Amoxicillin
Clindamycin
Clavulanic Acid
Amoxicillin-Potassium Clavulanate Combination
Immunoglobulins
Antibodies
Immunoglobulins, Intravenous
gamma-Globulins
Rho(D) Immune Globulin
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
beta-Lactamase Inhibitors