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Severe Pediatric Infectious ShockPedIRISNCT02848144

Pediatric Immune Response to Infectious Shock

A study testing blood samples and Collection of nosocomial infections in people with Severe Pediatric Infectious Shock, run by Hospices Civils de Lyon at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 1 month to 17 yearsHealthy volunteers can take part
Conditions the study is for
Severe Pediatric Infectious Shock
What is being tested?
blood samples and Collection of nosocomial infections
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
1 siteFrance
Study dates
26 Sep 2014to 4 Aug 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 month to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Children aged from 1 month to <18 years
  • Diagnosis of severe infectious shock at PICU or within the first 24 hours following PICU admission: severe sepsis or septic shock, defined by Surviving Sepsis Campaign 2012, or Toxic Shock Syndrome, defined by CDC criteria.
  • Healthy children aged matched to cases
  • Hospitalized for an elective surgery (dental, ENT, maxillofacial, urologic, hernia surgery, neurosurgery without massive hemorrhage)
  • Without any criteria of infection.

Who cannot join

  • Chronic inflammatory disease;
  • Immunodeficiency;
  • Long-term corticosteroids;
  • Ongoing immunosuppressive treatment;
  • Transplanted patients;
  • Tumors, hematological diseases;
  • No health insurance coverage;
  • Refusal to participate (from parents and/or patient) or inability to understand information.

Trial locations and contacts

1 site in 1 country.

France1 site
  • Hospices Civils de Lyon

    Lyon

Other trials in France

About this study

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.

Read more

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:

  • Immunological measures (mHLA -DR) in three stages: in the first 48 hours, between D3/5 and D7/9. The volume of collected blood will not exceed 2.4 ml / kg.
  • The collection of nosocomial infections and status at D30 A control group of patients hospitalized for surgery without sepsis or toxic shock criteria will be recruited in the same hospital by ICU investigators and matched for age. Similarly controls will be given oral and written information and they will have the opportunity to deny inclusion. They will have the same exams as the first group of patients.
Being tested
blood samples, Collection of nosocomial infections
Keywords
Immunoparalysis, immune response, sepsis, toxic shock syndrome
Medical subject headings
Sepsis, Shock, Septic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • blood samplesOther

  • Collection of nosocomial infectionsOther

Study groups in NCT02848144
Study groupRoleWhat they receive
Children with infectious shockOtherChildren 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.
Receives: Other: blood samples; Other: Collection of nosocomial infections
Control group: healthy childrenOtherHealthy 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.
Receives: Other: blood samples; Other: Collection of nosocomial infections

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. proportion of patients with a mHLA-DR level <30%

    mHLA-DR is measured by flow cytometry

    Measured: up to Day 9

  2. proportion of patients with a mHLA-DR level significantly lower than healthy children.

    mHLA-DR is measured by flow cytometry

    Measured: in the pre-operative period

Secondary outcomes (19)
  1. total lymphocytes

    From the whole blood samples, each lymphocytes sub-populations are determined by flow-cytometry with addition of specific monoclonal antibodies

    Measured: Day 1

  2. total lymphocytes

    From the whole blood samples, each lymphocytes sub-populations are determined by flow-cytometry with addition of specific monoclonal antibodies

    Measured: between Day 3 and day 5

  3. total lymphocytes

    From the whole blood samples, each lymphocytes sub-populations are determined by flow-cytometry with addition of specific monoclonal antibodies

    Measured: between Day 7 and day 9

  4. levels of CD4+

    From the whole blood samples, each lymphocytes sub-populations are determined by flow-cytometry with addition of specific monoclonal antibodies

    Measured: Day 1

  5. levels of CD4+

    From the whole blood samples, each lymphocytes sub-populations are determined by flow-cytometry with addition of specific monoclonal antibodies

    Measured: between Day 3 and day 5

  6. levels of CD4+

    From the whole blood samples, each lymphocytes sub-populations are determined by flow-cytometry with addition of specific monoclonal antibodies

    Measured: between Day 7 and day 9

  7. levels of CD25+

    From the whole blood samples, each lymphocytes sub-populations are determined by flow-cytometry with addition of specific monoclonal antibodies

    Measured: day 1

  8. levels of CD25+

    From the whole blood samples, each lymphocytes sub-populations are determined by flow-cytometry with addition of specific monoclonal antibodies

    Measured: between Day 3 and day 5

  9. levels of CD25+

    From the whole blood samples, each lymphocytes sub-populations are determined by flow-cytometry with addition of specific monoclonal antibodies

    Measured: between Day 7 and day 9

  10. 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

    Measured: Day 1

  11. 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

    Measured: between Day 3 and day 5

  12. 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

    Measured: between Day 7 and day 9

  13. dosage of cytokines

    Measured: Day 1

  14. dosage of cytokines

    Measured: between Day 3 and day 5

  15. dosage of cytokines

    Measured: between Day 7 and day 9

  16. Number of nosocomial infections

    Measured: up to Day 30

  17. Type of nosocomial infections

    bacteremia, ventilator-associated pneumonia, urinary tract infection, other sites.

    Measured: up to Day 30

  18. Mortality

    Measured: up to Day 30

  19. Length of vasoactive treatments

    Measured: up to Day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2016 (estimated)
  2. Study start26 Sep 2014
  3. Primary completion4 Aug 2018
  4. Study completion4 Aug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02848144
Sponsor's protocol ID
69HCL16_0478
Acronym
PedIRIS
Status last verified
Nov 2025
First submitted
21 Jul 2016
Last updated
21 Nov 2025
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Remy S, Kolev-Descamps K, Gossez M, Venet F, Demaret J, Javouhey E, Monneret G. Occurrence of marked sepsis-induced immunosuppression in pediatric septic shock: a pilot study. Ann Intensive Care. 2018 Mar 13;8(1):36. doi: 10.1186/s13613-018-0382-x.

    PubMed 29536210

Questions about this trial

What is this clinical trial studying?

A study testing blood samples and Collection of nosocomial infections in people with Severe Pediatric Infectious Shock, run by Hospices Civils de Lyon at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

proportion of patients with a mHLA-DR level <30% (time frame: up to Day 9). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02848144, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.

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