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Randomized Controlled Trial
. 2024 Aug 16;109(9):717-723.
doi: 10.1136/archdischild-2022-325274.

High-dose intravenous immunoglobulin versus albumin 4% in paediatric toxic shock syndrome: a randomised controlled feasibility study

Aurélie Portefaix  1   2 , Carole Dhelens  3 , Morgan Recher  4   5 , Fleur Cour-Andlauer  6 , Jérôme Naudin  7 , Guillaume Mortamet  8 , Nicolas Joram  9 , Pierre Tissières  10   11 , Tiphanie Ginhoux  12 , Behrouz Kassai  12   13 , Florent Boutitie  14 , Delphine Maucort-Boulch  14 , Etienne Javouhey  15   16
Affiliations
Randomized Controlled Trial

High-dose intravenous immunoglobulin versus albumin 4% in paediatric toxic shock syndrome: a randomised controlled feasibility study

Aurélie Portefaix et al. Arch Dis Child. .

Abstract

Purpose: Toxic shock syndrome (TSS) is a rare disease responsible for significant morbidity and mortality. Intravenous immunoglobulin (IG) therapy in paediatric TSS could improve shock and organ failure, but more consistent efficacy and safety data are needed. Our objective was to determine whether a randomised clinical trial (RCT) assessing intravenous IG in TSS in children is feasible.

Methods: We performed a multicentre, feasibility, double-blind RCT assessing efficacy of high-dose intravenous IG versus albumin 4% (control group) within the first 12 hours of shock onset. Included patients were aged above 1 month and below 18 years with suspected TSS and septic shock. Feasibility was assessed by measuring inclusion rate, protocol compliance and missing data regarding death and the Pediatric Logistic Organ Dysfunction-2 (PELOD-2) Score. Other secondary clinical outcomes were evaluated during hospital stay, at 60 day and 1 year.

Results: 28 patients, admitted in 6 paediatric intensive care units during 36 consecutive months and followed for 1 year, received the allocated treatment: 13 in intravenous IG group, 15 in control group. The median age was 10.6 years and the sex ratio was 1. Inclusion rate was above 50%, protocol deviations were below 30% and missing data regarding death and PELOD-2 Score below 10%. No difference concerning secondary clinical outcomes between groups was observed, and more adverse events were reported in the control group.

Conclusion: It seems to be feasible to conduct an RCT assessing intravenous IG efficacy and safety in paediatric TSS but must be realised internationally, with choice of a clinically relevant endpoint and a specific design in order to be realistic.

Trial registration number: NCT02219165.

Keywords: Infectious Disease Medicine; Intensive Care Units, Paediatric; Paediatrics; Sepsis.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Flow chart of the trial. The control group consists of patients treated with albumin 4%. IVIG, intravenous immunoglobulin; PICU, paediatric intensive care unit.
Figure 2
Figure 2
Evolution of Pediatric Logistic Organ Dysfunction-2 (PELOD-2) Score variation during the first 5 days according to treatment group. The control group (blue boxes) consists of patients treated with albumin 4%. The intravenous immunoglobulin (IVIG) group (red boxes) consists of patients treated with Intravenous Immunoglobulin.
Figure 3
Figure 3
Pediatric Glasgow Outcome Scale Extended (GOS-E-Peds) at 1 year in each allocated group. The control group consists of patients treated with albumin 4%. The intravenous Immunoglobulin (IVIG) group (red boxes) consists of patients treated with intravenous immunoglobulin
See this image and copyright information in PMC

References

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