Background and Aims

Background and aims: Superantigen toxins synthesized by Staphylococcus aureus and Streptococcus pyogenes are responsible for toxic shock syndromes (TSS), which lethality can reach 28% in children. In vitro, high concentration of Intravenous Immunoglobulins (IVIG) neutralize their toxicity. No randomized controlled trial (RCT) on IVIG efficacy in TSS has been conducted in children.

Before launching such a prospective RCT, a pilot study is required, with objective to assess the feasibility including inclusion rate, protocol deviations, and missing data.

Methods

We performed a multicenter, double-blind, pilot RCT. We planned to recruit, over 24 months, 20 patients with suspicion of TSS and criteria of septic shock, aged from 1 month to 18 years, admitted within 9 French paediatric intensive care units. The experimental group received IVIG10% (2g/kg) and the control group Albumin4% (0,8g/kg). There were 12 months of follow-up.

Results

79 children with TSS were assessed for eligibility, including 49 eligible, among which 30 (61%) were recruited within 38 months. Median Pelod 2 score at inclusion was 6 (0-11). 29 patients received allocated treatment (97%) and 9 patients (30%) had at least one protocol deviation. There were no missing data on key data for primary endpoint. 9 patients (30%) presented serious adverse events (no death)

Conclusions

This first RCT in paediatric TSS shows the feasibility of such a trial with only a few adjustments. As recommended by the Data Safety Monitoring Board, an international multicentre efficacy study is required to perform this trial.