Can immune antibodies fight toxic shock in kids? small trial hopes to find out
NCT ID NCT02219165
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study tested whether giving intravenous immunoglobulin (IVIG) to children with toxic shock syndrome is practical and might help. Toxic shock is a rare but life-threatening reaction to bacterial toxins. The trial enrolled 30 children in intensive care, giving them either IVIG or a placebo (albumin) within 12 hours of shock. The main goal was to see if such a study could be done smoothly, not to prove IVIG works. Researchers also tracked organ failure and side effects to guide a future larger trial.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Intravenous immunoglobulin (IVIG)
- What this could lead to
- If this pilot shows IVIG is feasible and reduces organ failure, it could lead to a larger trial testing whether IVIG can save more children from toxic shock.
- What could go wrong
- This is a small pilot study (30 children) focused on feasibility, not on proving that IVIG works. The treatment is expensive and not yet approved for toxic shock, so results may not lead to a proven therapy.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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30 people
The number who actually took part.
- Started
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Jan 2015
- Finished
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Apr 2019
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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1 month to 17 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hôpital Femme Mère Enfant
Bron, 69677, France
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