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.
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.
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.
- Conditions
- Severe Pediatric Infectious Shock
- 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 group | Role | What they receive |
|---|---|---|
| Children with infectious shock | Other | 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. Receives: Other: blood samples; Other: Collection of nosocomial infections |
| Control group: healthy children | Other | 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. 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.
proportion of patients with a mHLA-DR level <30%
mHLA-DR is measured by flow cytometry
Measured: up to Day 9
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)
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
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
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
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
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
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
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
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
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
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
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
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
dosage of cytokines
Measured: Day 1
dosage of cytokines
Measured: between Day 3 and day 5
dosage of cytokines
Measured: between Day 7 and day 9
Number of nosocomial infections
Measured: up to Day 30
Type of nosocomial infections
bacteremia, ventilator-associated pneumonia, urinary tract infection, other sites.
Measured: up to Day 30
Mortality
Measured: up to Day 30
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.
- First posted28 Jul 2016 (estimated)
- Study start26 Sep 2014
- Primary completion4 Aug 2018
- Study completion4 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe Pediatric Infectious ShockStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Etienne JAVOUHEY, Principal investigator, Hospices Civils de Lyon
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Immune Response to Infectious Shock
- ClinicalTrials.gov ID
- NCT02848144
- Acronym / sponsor ID
- PedIRIS / 69HCL16_0478
- Conditions
- Severe Pediatric Infectious Shock
- Keywords
- Immunoparalysis, immune response, sepsis, toxic shock syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 26 Sep 2014 (actual)
- Primary completion
- 4 Aug 2018 (actual)
- Study completion
- 4 Aug 2018 (actual)
- First posted
- 28 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with infectious shock | Other | Other: blood samples, Other: Collection of nosocomial infectionsChildren 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. |
| Control group: healthy children | Other | Other: blood samples, Other: Collection of nosocomial infectionsHealthy 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. |
Who may qualify
- Ages
- 1 month to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- Chronic inflammatory disease;
- Immunodeficiency;
- Long-term corticosteroids;
- Ongoing immunosuppressive treatment;
- Transplanted patients;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samples | Other | Children with infectious shock, Control group: healthy children |
| Collection of nosocomial infections | Other | Children with infectious shock, Control group: healthy children |
Primary outcome
proportion of patients with a mHLA-DR level <30%
Time frame: up to Day 9
mHLA-DR is measured by flow cytometry
proportion of patients with a mHLA-DR level significantly lower than healthy children.
Time frame: in the pre-operative period
mHLA-DR is measured by flow cytometry
19 secondary outcomes
total lymphocytes
Time frame: Day 1
total lymphocytes
Time frame: between Day 3 and day 5
total lymphocytes
Time frame: between Day 7 and day 9
levels of CD4+
Time frame: Day 1
levels of CD4+
Time frame: between Day 3 and day 5
levels of CD4+
Time frame: between Day 7 and day 9
levels of CD25+
Time frame: day 1
levels of CD25+
Time frame: between Day 3 and day 5
levels of CD25+
Time frame: between Day 7 and day 9
levels of T lymphocytes (Treg)
Time frame: Day 1
levels of T lymphocytes (Treg)
Time frame: between Day 3 and day 5
levels of T lymphocytes (Treg)
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
Time frame: up to Day 30
Mortality
Time frame: up to Day 30
Length of vasoactive treatments
Time frame: up to Day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Results publication: PubMed 29536210Remy 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Etienne JAVOUHEY principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
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.