Primary ImmunodeficiencyDIPREANCT04356053
Systematic Screening for Primary Immunodeficiencies in Patients Hospitalized for Severe Infections in Intensive Care.
An observational study of Primary Immunodeficiency, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Currently about 90 cases of infection in children are reported every year in pediatric intensive care, a disease considered to be the main cause of hospitalization of children. 16% of invasive pneumococcal infections are linked to a genetic abnormality in immunity. Read more about this study
- Who is it for?
- Ages 1 month to 16 years
- Conditions the study is for
- Primary Immunodeficiency
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2020to 30 Dec 2021
- Phase
- Observational
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric population
Who may be able to join
- Subject aged 1 month to 16 years.
- Admission in pediatric ICU for more than 24h.
- Documented severe infection (bacterial, viral, fungal).
- Child benefiting from a social security scheme.
- Collection of parental consent / legal representatives.
Who cannot join
- Prematurity (gestational age <37 weeks of gestation) up to 6 months of age.
- Undocumented severe infections.
- Children entered for isolated RSV bronchiolitis, with no other infectious related complications.
- Previous comorbidity explaining the infection and/or the stay in intensive care / continuous care: known primary or secondary immunodeficiency; burned; risk factors for status epilepticus (encephalopathy, known epilepsy, head trauma), pneumonia or asthma (swallowing disorders, tracheotomy, chronic pulmonary pathology, asthma), meningitis (cochlear implants, breccia, neuromeningeal material), deep infection (implanted material, recent surgery), cardiovascular decompensation.
- Any other chronic pathology favoring an infection
- Impossibility to obtain the consent of parents / legal representatives.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Uhmontpellier
Montpellier, 34295
Gabrielle VIGUE, Doctor, 04 67 33 67 33 ext. 33
claire LOZANO, Doctor, 04 67 33 67 33 ext. 33, c-lozano@chu-montpellier.fr
About this study
Official title: Systematic Screening for Primary Immunodeficiencies in Patients Hospitalized for Severe Infections in Intensive Care : DIPREA
Currently about 90 cases of infection in children are reported every year in pediatric intensive care, a disease considered to be the main cause of hospitalization of children. 16% of invasive pneumococcal infections are linked to a genetic abnormality in immunity. Herpetic encephalitis has become a model of genetic infectious disease, with new mutations identified in the TLR3 pathway. Severe infections are no longer the result of chance and can be the way to reveal a primary immune deficiency. In this context, the investigators propose to evaluate the incidence of hereditary immune deficiency after a systematic immunological screening in children admitted for a severe infection in pediatric intensive care unit (ICU).
Read the detailed description
Severe infection requiring admission in intensive care unit (ICU) are not so rare. A retrospective pilot study conducted at Montpellier University Hospital Center (UHC) between 2013 and 2015 showed that 19.7% of the pediatric ICU admissions were related to a severe infection. An isolated severe infectious episode could be related to a hereditary immune deficiency (HID), even though there are no history of recurrent clinical signs and biological stigmata. For example, Gaschignard and colleagues considered that 16% of the invasive pneumococcal infections are related to a genetic defect of immunity (doi: 10.1093/cid/ciu274). Growing evidence has shown that severe infectious diseases occurring in childhood are attributed to inborn errors of immunity (doi: 10.1073/pnas.1521651112). While the nosology of severe infections has strong links to inherited immune deficiency that are rare diseases affecting less than 1 birth / 5000, there are no prospective studies that assessed the incidence of primary immune deficiencies in children who presented a severe infection.
- Conditions
- Primary Immunodeficiency
- Keywords
- severe infection, pediatric
- Medical subject headings
- Primary Immunodeficiency Diseases, Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunological abnormalities
Immunological abnormalities : based on the screening test
Measured: 1 day
Secondary outcomes (1)
Diagnosis of primary immunodeficiency
Diagnosis of primary immunodeficiency
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start1 Apr 2020
- Primary completion1 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary ImmunodeficiencyStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabrielle VIGUE, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04356053
- Sponsor's protocol ID
- RECHMPL20_0199
- Acronym
- DIPREA
- Status last verified
- Oct 2021
- First submitted
- 17 Apr 2020
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Screening for Primary Immunodeficiencies in Patients Hospitalized for Severe Infections in Intensive Care : DIPREA
- ClinicalTrials.gov ID
- NCT04356053
- Acronym / sponsor ID
- DIPREA / RECHMPL20_0199
- Conditions
- Primary Immunodeficiency
- Keywords
- severe infection, pediatric
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 22 Apr 2020 (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.
Currently about 90 cases of infection in children are reported every year in pediatric intensive care, a disease considered to be the main cause of hospitalization of children. 16% of invasive pneumococcal infections are linked to a genetic abnormality in immunity. Herpetic encephalitis has become a model of genetic infectious disease, with new mutations identified in the TLR3 pathway. Severe infections are no longer the result of chance and can be the way to reveal a primary immune deficiency. In this context, the investigators propose to evaluate the incidence of hereditary immune deficiency after a systematic immunological screening in children admitted for a severe infection in pediatric intensive care unit (ICU).
Detailed description
Severe infection requiring admission in intensive care unit (ICU) are not so rare. A retrospective pilot study conducted at Montpellier University Hospital Center (UHC) between 2013 and 2015 showed that 19.7% of the pediatric ICU admissions were related to a severe infection. An isolated severe infectious episode could be related to a hereditary immune deficiency (HID), even though there are no history of recurrent clinical signs and biological stigmata. For example, Gaschignard and colleagues considered that 16% of the invasive pneumococcal infections are related to a genetic defect of immunity (doi: 10.1093/cid/ciu274). Growing evidence has shown that severe infectious diseases occurring in childhood are attributed to inborn errors of immunity (doi: 10.1073/pnas.1521651112). While the nosology of severe infections has strong links to inherited immune deficiency that are rare diseases affecting less than 1 birth / 5000, there are no prospective studies that assessed the incidence of primary immune deficiencies in children who presented a severe infection.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 month to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric population
Key inclusion criteria (5 listed)
- Subject aged 1 month to 16 years.
- Admission in pediatric ICU for more than 24h.
- Documented severe infection (bacterial, viral, fungal).
- Child benefiting from a social security scheme.
- Collection of parental consent / legal representatives.
Key exclusion criteria (6 listed)
- Prematurity (gestational age <37 weeks of gestation) up to 6 months of age.
- Undocumented severe infections.
- Children entered for isolated RSV bronchiolitis, with no other infectious related complications.
- Previous comorbidity explaining the infection and/or the stay in intensive care / continuous care: known primary or secondary immunodeficiency; burned; risk factors for status epilepticus (encephalopathy, known epilepsy, head trauma), pneumonia or asthma (swallowing disorders, tracheotomy, chronic pulmonary pathology, asthma), meningitis (cochlear implants, breccia, neuromeningeal material), deep infection (implanted material, recent surgery), cardiovascular decompensation.
- Any other chronic pathology favoring an infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Immunological abnormalities
Time frame: 1 day
Immunological abnormalities : based on the screening test
1 secondary outcome
Diagnosis of primary immunodeficiency
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- Individual participant dataSharing planned: Undecided. NC
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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. This study is not recruiting at the moment.
Gabrielle VIGUE principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Immunodeficiency, run by University Hospital, Montpellier 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 6 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: status not confirmed, as of the sponsor's last update on 12 Oct 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eric JEZIORSKI (04 67 33 57 98 ext. 33, e-jeziorski@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunological abnormalities (time frame: 1 day). 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 12 Oct 2021.