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

Staphylococcal Infection Clinical Trial

— IGHN2  

Official title:

Effectiveness of Intravenous Immunoglobulins (IVIG) in Toxic Shock Syndromes in Children: a Multicentre European Randomized Controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02899702
• Other study ID #: 69HCL16_0079
• Status: Withdrawn
• Phase: Phase 4
• Start date: September 2020
• Est. completion date: September 2024

Study information

• Verified date: April 2021
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Shock, Septic
• Staphylococcal Infection
• Staphylococcal Infections
• Streptococcal Infection
• Streptococcal Infections

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Hôpital Femme Mère Enfant	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	organ dysfunctions	Average variation in Pediatric Logistic Organ Dysfunction 2 ( PELOD-2) score compared between the IVIG treatment arm and the placebo arm.	between day of admission and day 3
Secondary	global mortality		1 year
Secondary	disability assessed by the Pediatric Overall Performance Category (POPC) score		one year after recruitment
Secondary	impairment assessed by the Vineland Adaptive Behavior Scale 2 (VABS II)		one year after recruitment
Secondary	organ dysfunctions assessed by the PELOD-2 score		over the first 5 days in Paediatric Intensive Care Unit (PICU)