An interventional study of blood samples and Collection of nosocomial infections in Severe Pediatric Infectious Shock, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 1 Month to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-21.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Basic science
Infectious shocks are associated with high mortality rates (20-40%). Anti-inflammatory strategies based on the postulate that mortality related to sepsis is mainly due to an overwhelming pro-inflammatory immune response have failed. Some patients surviving this initial phase can develop immune dysfunctions because the compensatory mechanisms become deleterious when they persist over time. The persistence of immunosuppression at day 3 or 5 is independently associated with more nosocomial infections and higher mortality rate. The clinical and laboratory evidence for sepsis induced immunosuppression have been recently reviewed by Hotchkiss et al. Apoptosis-induced depletion of immune effector and blood studies from septic patients showed decreased production of pro-inflammatory cytokines, decreased HLA-DR expression, increased percentage of regulatory T cells, and increased production of programmed cell death (PD)-1. Some small positive phase 2 trials of biomarker guided immune enhancing agents granulocyte-macrophage colony stimulating factor (GM-CSF) and interferon γ (IFN γ) have been reported.
There are insufficient data showing that such an immunosuppression exists in children. Only one study performed in children with organ dysfunctions admitted to pediatric intensive care unit (PICU), showed that 34% of them developed immunosuppression. This study was performed on a heterogeneous population and immunological analyses were limited. Therefore, there is a crucial need of studies on septic patients with matched controls to provide more evidence that the same paradigm exists in children. The collaboration of laboratories with a high level of experience in this domain, and a clinical unit with a high potential of recruitment of children with severe infectious shock should allow us to perform the first prospective study specifically done in children with infectious shock.
The main hypothesis is that children with severe infectious shock developed sepsis-induced immunosuppression as shown in adults. This will be assessed by the expression of HLA-DR on monocytes' surface. We make the hypothesis that children who become immunosuppressed are more prone to develop secondary nosocomial infectious and stayed longer in PICU and in hospital.
Children aged from 1 month to 17 years, admitted to PICU at HFME Lyon-Bron are eligible if they have the criteria for severe sepsis or septic shock, defined by the "Surviving Sepsis Campaign 2012" or those of Toxic Shock Syndrome (TSS) (definitions of CDC - Center for Disease Control). An information leaflet will be issued to parents and children / adolescents and they will be informed of their right to object to the search. Are provided as part of this research:
1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.
This study's enrollment of 105 is close to the median of 105 across 896 interventional studies indexed under Sepsis.
Browse Sepsis studies →Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria Infectious shock group:
Inclusion Criteria Control group:
Exclusion Criteria (both groups):
Children aged from 1 month to \<18 years. In 3 stratified groups : \<2 years, 2-8 years, and \>8 years. About one third of the patients are expected in each age-group.
Other: blood samples · Other: Collection of nosocomial infections
Healthy children aged-matched to cases (same stratification group, about 20 per age group); They will be hospitalized for an elective surgery (dental, ENT, maxillofacial, urologic, hernia surgery, neurosurgery without massive hemorrhage) and without any infection.
Other: blood samples · Other: Collection of nosocomial infections
proportion of patients with a mHLA-DR level <30%
mHLA-DR is measured by flow cytometry
Time frame: up to Day 9
proportion of patients with a mHLA-DR level significantly lower than healthy children.
mHLA-DR is measured by flow cytometry
Time frame: in the pre-operative period
total lymphocytes
From the whole blood samples, each lymphocytes sub-populations are determined by flow-cytometry with addition of specific monoclonal antibodies
Time frame: Day 1
total lymphocytes
From the whole blood samples, each lymphocytes sub-populations are determined by flow-cytometry with addition of specific monoclonal antibodies
Time frame: between Day 3 and day 5
total lymphocytes
From the whole blood samples, each lymphocytes sub-populations are determined by flow-cytometry with addition of specific monoclonal antibodies
Time frame: between Day 7 and day 9
levels of CD4+
From the whole blood samples, each lymphocytes sub-populations are determined by flow-cytometry with addition of specific monoclonal antibodies
Time frame: Day 1
levels of CD4+
From the whole blood samples, each lymphocytes sub-populations are determined by flow-cytometry with addition of specific monoclonal antibodies
Time frame: between Day 3 and day 5
levels of CD4+
From the whole blood samples, each lymphocytes sub-populations are determined by flow-cytometry with addition of specific monoclonal antibodies
Time frame: between Day 7 and day 9
levels of CD25+
From the whole blood samples, each lymphocytes sub-populations are determined by flow-cytometry with addition of specific monoclonal antibodies
Time frame: day 1
levels of CD25+
From the whole blood samples, each lymphocytes sub-populations are determined by flow-cytometry with addition of specific monoclonal antibodies
Time frame: between Day 3 and day 5
levels of CD25+
From the whole blood samples, each lymphocytes sub-populations are determined by flow-cytometry with addition of specific monoclonal antibodies
Time frame: between Day 7 and day 9
levels of T lymphocytes (Treg)
From the whole blood samples, each lymphocytes sub-populations are determined by flow-cytometry with addition of specific monoclonal antibodies
Time frame: Day 1
levels of T lymphocytes (Treg)
From the whole blood samples, each lymphocytes sub-populations are determined by flow-cytometry with addition of specific monoclonal antibodies
Time frame: between Day 3 and day 5
levels of T lymphocytes (Treg)
From the whole blood samples, each lymphocytes sub-populations are determined by flow-cytometry with addition of specific monoclonal antibodies
Time frame: between Day 7 and day 9
dosage of cytokines
Time frame: Day 1
dosage of cytokines
Time frame: between Day 3 and day 5
dosage of cytokines
Time frame: between Day 7 and day 9
Number of nosocomial infections
Time frame: up to Day 30
Type of nosocomial infections
bacteremia, ventilator-associated pneumonia, urinary tract infection, other sites.
Time frame: up to Day 30
Mortality
Time frame: up to Day 30
Length of vasoactive treatments
Time frame: up to Day 30
Plan to share: No
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Hospices Civils de Lyon