WithdrawnPhase 4

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

Stopped: no EC approval obtained

France0Started 2020-09

Plain-language 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.

Who can participate

Age range1 Month – 17 Years

SexALL

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Inclusion criteria

✓. Toxic Shock Syndrom as defined by Centre for Disease Control criteria
✓. or group A Streptococcus necrotizing fasciitis (positive streptest)
✓. or varicella with infected lesions and rash or positive streptest
✓. or erythrodermic rash in menstrual period
✓. or pleuropneumonia with erythrodermic rash or positive streptest in pleural fluid
✓. or erythrodermic rash and biological fluid positive to streptococcus A or staphylococcus (articular, pericardial, bronchopulmonary, pharynx)
✓. hypotension (\< 5th percentile)
✓. or systolic blood pressure \< 2 SD regarding age

What they're measuring

organ dysfunctions

Timeframe: between day of admission and day 3

Trial details

NCT IDNCT02899702

SponsorHospices Civils de Lyon

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09

View on ClinicalTrials.gov More Staphylococcal Infection trials