Severe Bacterial InfectionsIBSoFACToNCT07111793
Identification of Clinical, Genetic and Immunological Factors Involved in the Development of Severe Bacterial Infections in Pediatrics
A study testing Extended phenotyping, Blood sample for WES and Blood sample for PBMC freezing in people with Severe Bacterial Infections, run by Nantes University Hospital at 7 sites in France.
Trial summary
Severe bacterial infections (SBI) are responsible for significant morbidity and mortality in the paediatric population. There is considerable individual variability in children's susceptibility to developing SBIs. This variability is multifactorial, and the mechanisms at work are not yet fully understood. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Severe Bacterial Infections
- What is being tested?
- Extended phenotyping, Blood sample for WES and Blood sample for PBMC freezing
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,401 participants
- Where
- 7 sitesFrance
- Study dates
- 18 Mar 2026to 18 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- For patients:
- Patient included in the DIABACT IV study between 2015 and 2018, following hospitalization in a pediatric intensive care unit in France for a severe bacterial infection.
- Patient affiliated to a social security system
- Patient alive at the time of inclusion.
- Written consent from legal representatives for participation in research. If one of the legal representatives is unable to complete/sign the written consent, it will be sought orally by telephone and recorded in the patient's file. If the patient is over 18, written consent will be obtained. If the patient is a minor, consent will be sought with communication adapted to his/her level of understanding and age.
- For parents:
- Patient's biological parents
- Written consent
Who cannot join
- Persons under court protection
- Refusal to participate in research
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sponsor Department contact
7 sites in 1 country
France7 sites, 7 recruiting
- Not yet recruiting
CHU de Brest
Brest
Jean-Michel ROUÉ, MD, 02 98 22 32 53, jean-michel.roue@chu-brest.fr
Jean-Michel ROUÉ, MD
- Not yet recruiting
Hospices Civils de Lyon
Lyon
Etienne JAVOUHEY, MD, 04 72 12 97 36, etienne.javouhey@chu-lyon.fr
Etienne JAVOUHEY, MD
- Not yet recruiting
CHU Montpellier
Montpellier
Marie Gabrielle VIGUÉ, +33 4 67 33 22 86, mg-vigue@chu-montpellier.fr
Marie Gabrielle VIGUÉ
- Recruiting
Nantes University Hospital
Nantes, Loire Atlantique, 44093
Élise LAUNAY, 2 98 22 32 53 ext. +33, elise.launay@chu-nantes.fr
Elide LAUNAY
- Not yet recruiting
Hôpital Armand Trousseau
Paris
Sandrine JEAN, MD, 01 44 73 60 65, sandrine.jean@aphp.fr
Sandrine JEAN, MD
- Not yet recruiting
Hôpital Necker enfants malades
Paris
Julie TOUBIANA, MD, 01 44 49 40 00, julie.toubiana@aphp.fr
Julie TOUBIANA, MD
- Not yet recruiting
CHU de Saint-Étienne
Saint-Etienne
Hugues PATURAL, MD, 04 77 82 81 17, hugues.patural@univ-st-etienne.fr
Hugues PATURAL, MD
About this study
Official title: IBSoFACTo : Identification of Clinical, Genetic and Immunological Factors Involved in the Development of Severe Bacterial Infections in Pediatrics
Severe bacterial infections (SBI) are responsible for significant morbidity and mortality in the paediatric population. There is considerable individual variability in children's susceptibility to developing SBIs. This variability is multifactorial, and the mechanisms at work are not yet fully understood. The investigators of this study therefore propose to study a population of children who had particularly severe bacterial infections requiring hospitalization in a pediatric intensive care unit in France between 2015 and 2018. This study is part of a global approach to understanding the mechanisms favoring the occurrence of IBS in pediatrics.
The study will initially focus on analyzing the clinical phenotype of these children in terms of the type of infection presented, as well as immunologically with an immune workup of all these patients. The investigators also plan to contact each family individually to identify other episodes of personal or family IBS or other elements suggestive of immune deficiency (opportunistic infections, autoimmune manifestations, severe atopy). The investigators will also assess the persistent sequelae since their infectious episode, and their quality of life following this IBS.
In parallel, the genetic analysis of these patients and their parents will be carried out using whole-exome sequencing. The investigators will compare the results with those obtained in 2 IBS-free control populations (N=70 and N=116). The goal is to identify genetic variants that favor the occurrence of IBS in general, and some that are specific to certain bacteria or clinical presentations.
- Conditions
- Severe Bacterial Infections
- Being tested
- Extended phenotyping, Blood sample for WES, Blood sample for PBMC freezing, POPC score evaluation, Questionnaire completion
- Keywords
- Severe bacterial infections, Whole-exome sequencing, Inborn errors of immunity, pediatrics
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended phenotypingOther
Extended phenotyping (analysis performed at Nantes University Hospital, MANDATORY DELIVERY WITHIN 24 HOURS) = 1 EDTA 3 mL tube for patients included in Nantes.
Blood sample for WESOther
Blood sample for WES : 1 x 3 mL EDTA tube (if not included in DIABACT IV biocollection)
Blood sample for PBMC freezingOther
Blood sample for PBMC freezing integrated into the biocollection: 1 EDTA tube = 3 mL
POPC score evaluationOther
Assessment of POPC score (Pediatric Overall Performance Category)
Questionnaire completionOther
Questionnaires completed by parents or children:
- SDQ
- PedSQL4.0
| Study group | Role | What they receive |
|---|---|---|
| Patients with severe childhood bacterial infections | Other | Patient inclus dans l'étude DIABACT IV (NCT02167802) entre 2015 et 2018, dans les suites de son hospitalisation en réanimation pédiatrique en France pour une infection bactérienne sévère. Receives: Other: Extended phenotyping; Other: Blood sample for WES; Other: Blood sample for PBMC freezing; Other: POPC score evaluation; Other: Questionnaire completion |
| Patient's biological parents | Other | Not described Receives: Other: Blood sample for WES; Other: Questionnaire completion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of innate errors of immunity involved in the development of IBS in pediatrics.
List of rare genetic variants significantly more frequently found in cases than in controls and/or absent in healthy parents.
Measured: At the enrollment
Secondary outcomes (6)
Identification of inborn errors of immunity involved in the development of IBS and their association with abnormalities of the immune balance,
Measured: At the enrollment
Identification of rare genetic variants favoring certain clinical types of infection, or certain biological and immunological abnormalities.
Measured: At the enrollment
Identification of immune deficiencies in patients who have developed a severe bacterial infection
Measured: At the enrollment
Assessment of sequelae with the POPC sequelae score (Pediatric Overall Performance Category) at a distance from the IBS episode.
The POPC sequelae score is a scale from 1 to 6, with 6 being the worst possible outcome.
Measured: At the enrollment
Assessment of sequelae at a distance from the IBS episode with the Strengths and Weaknesses Questionnaire (SDQ-Fra).
The SDQ-Fra score is a scale from 0 to 2, with 2 being the worst possible outcome.
Measured: At the enrollment
Assessment of quality of life at a distance from the IBS episode.
Quality of life will be assessed in this patient population using the Pediatric Quality of Life InventoryTM (scale from 0 to 4, with 4 corresponding to the worst outcome).
Measured: At the enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start18 Mar 2026
- Primary completion18 Dec 2027 (estimated)
- Study completion18 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Bacterial InfectionsStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,401 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07111793
- Sponsor's protocol ID
- RC25_0061
- Other IDs
- 2025-A01367-42
- Acronym
- IBSoFACTo
- Status last verified
- Oct 2026
- First submitted
- 17 Jul 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IBSoFACTo : Identification of Clinical, Genetic and Immunological Factors Involved in the Development of Severe Bacterial Infections in Pediatrics
- ClinicalTrials.gov ID
- NCT07111793
- Acronym / sponsor ID
- IBSoFACTo / RC25_0061
- Conditions
- Severe Bacterial Infections
- Keywords
- Severe bacterial infections, Whole-exome sequencing, Inborn errors of immunity, pediatrics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,401 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 18 Mar 2026 (actual)
- Primary completion
- 18 Dec 2027 (estimated)
- Study completion
- 18 Dec 2029 (estimated)
- First posted
- 8 Aug 2025 (actual)
- 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.
Severe bacterial infections (SBI) are responsible for significant morbidity and mortality in the paediatric population. There is considerable individual variability in children's susceptibility to developing SBIs. This variability is multifactorial, and the mechanisms at work are not yet fully understood. The investigators of this study therefore propose to study a population of children who had particularly severe bacterial infections requiring hospitalization in a pediatric intensive care unit in France between 2015 and 2018. This study is part of a global approach to understanding the mechanisms favoring the occurrence of IBS in pediatrics.
The study will initially focus on analyzing the clinical phenotype of these children in terms of the type of infection presented, as well as immunologically with an immune workup of all these patients. The investigators also plan to contact each family individually to identify other episodes of personal or family IBS or other elements suggestive of immune deficiency (opportunistic infections, autoimmune manifestations, severe atopy). The investigators will also assess the persistent sequelae since their infectious episode, and their quality of life following this IBS.
In parallel, the genetic analysis of these patients and their parents will be carried out using whole-exome sequencing. The investigators will compare the results with those obtained in 2 IBS-free control populations (N=70 and N=116). The goal is to identify genetic variants that favor the occurrence of IBS in general, and some that are specific to certain bacteria or clinical presentations.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with severe childhood bacterial infections | Other | Other: Extended phenotyping, Other: Blood sample for WES, Other: Blood sample for PBMC freezing, Other: POPC score evaluation, Other: Questionnaire completionPatient inclus dans l'étude DIABACT IV (NCT02167802) entre 2015 et 2018, dans les suites de son hospitalisation en réanimation pédiatrique en France pour une infection bactérienne sévère. |
| Patient's biological parents | Other | Other: Blood sample for WES, Other: Questionnaire completion |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Patient included in the DIABACT IV study between 2015 and 2018, following hospitalization in a pediatric intensive care unit in France for a severe bacterial infection.
- Patient affiliated to a social security system
- Patient alive at the time of inclusion.
- Written consent from legal representatives for participation in research. If one of the legal representatives is unable to complete/sign the written consent, it will be sought orally by telephone and recorded in the patient's file. If the patient is over 18, written consent will be obtained. If the patient is a minor, consent will be sought with communication adapted to his/her level of understanding and age.
- Patient's biological parents
Key exclusion criteria (2 listed)
- Persons under court protection
- Refusal to participate in research
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 |
|---|---|---|
| Extended phenotypingExtended phenotyping (analysis performed at Nantes University Hospital, MANDATORY DELIVERY WITHIN 24 HOURS) = 1 EDTA 3 mL tube for patients included in Nantes. | Other | Patients with severe childhood bacterial infections |
| Blood sample for WESBlood sample for WES : 1 x 3 mL EDTA tube (if not included in DIABACT IV biocollection) | Other | Patient's biological parents, Patients with severe childhood bacterial infections |
| Blood sample for PBMC freezingBlood sample for PBMC freezing integrated into the biocollection: 1 EDTA tube = 3 mL | Other | Patients with severe childhood bacterial infections |
| POPC score evaluationAssessment of POPC score (Pediatric Overall Performance Category) | Other | Patients with severe childhood bacterial infections |
| Questionnaire completionQuestionnaires completed by parents or children: * SDQ * PedSQL4.0 | Other | Patient's biological parents, Patients with severe childhood bacterial infections |
Primary outcome
Identification of innate errors of immunity involved in the development of IBS in pediatrics.
Time frame: At the enrollment
List of rare genetic variants significantly more frequently found in cases than in controls and/or absent in healthy parents.
6 secondary outcomes
Identification of inborn errors of immunity involved in the development of IBS and their association with abnormalities of the immune balance,
Time frame: At the enrollment
Identification of rare genetic variants favoring certain clinical types of infection, or certain biological and immunological abnormalities.
Time frame: At the enrollment
Identification of immune deficiencies in patients who have developed a severe bacterial infection
Time frame: At the enrollment
Assessment of sequelae with the POPC sequelae score (Pediatric Overall Performance Category) at a distance from the IBS episode.
Time frame: At the enrollment
Assessment of sequelae at a distance from the IBS episode with the Strengths and Weaknesses Questionnaire (SDQ-Fra).
Time frame: At the enrollment
Assessment of quality of life at a distance from the IBS episode.
Time frame: At the enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
Sponsor Department contact
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extended phenotyping, Blood sample for WES and Blood sample for PBMC freezing in people with Severe Bacterial Infections, run by Nantes University Hospital at 7 sites 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 8 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elise LAUNAY (2 40 08 31 79 ext. +33, elise.launay@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of innate errors of immunity involved in the development of IBS in pediatrics. (time frame: At the enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2026.