Primary Immune Deficiency DisorderICUSPIDNCT02888535
Intensive Care Unit and Secondary and Primary Immune Deficiency
An observational study of Primary Immune Deficiency Disorder, run by University Hospital, Caen at 1 site in France.
Trial summary
Primary immune deficiencies (PID) are characterized by a failure of the immune system that is not explained by any infectious, neoplastic, or iatrogenic cause. In 2015, more than 300 different inherited rare disorders were described. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Primary Immune Deficiency Disorder
- What is being tested?
- Internal Medicine consultation
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to Dec 2019
- How long will I take part?
- 6 Months
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18 to 65, hospitalized in medical intensive care unit for a severe or opportunistic infection or an idiopathic hemophagocytic syndrome, without any known warning sign or predisposing factor, were included.
Who may be able to join
- Aged 18-65
- Hospitalized in medical intensive care unit for :
- Severe infection without pathogen identification
- Severe infection due to encapsuled pathogen
- Opportunistic infections or unusual pathogen
- Idiopathic hemophagocytic syndrome
Who cannot join
- primary immunodeficiency already known
- secondary immunodeficiency already known (HIV, cancer, immunosuppressive or immunomodulatory treatment, nephrotic syndrome, protein-losing enteropathy, severe malnutrition before admission, cirrhosis with hepatic failure, sickle cell disease, splenectomy and moderate chronic renal failure (clearance between 30 and 59 m² min/1.73 ml)
- local-regional factors which can be responsible for infections (history of ear, nose and throat surgery or neurosurgery, history of fracture of the skull base, cystic fibrosis, chronic respiratory insufficient)
Trial locations and contacts
1 site in 1 country.
About this study
Primary immune deficiencies (PID) are characterized by a failure of the immune system that is not explained by any infectious, neoplastic, or iatrogenic cause. In 2015, more than 300 different inherited rare disorders were described. The occurrence of PID in adult is rare and diagnosis may be supported by the 6 ESID signs for adult. However these warnings signs are based only on expert recommendations and do not include comprehensive symptoms of PIDs. Recurrent infections, more aggressive, are the most common mode of revelation of the PID. Less frequently, autoimmune manifestation, solid tumor, lymphoproliferation tumor, chronic granulomatosis or hemophagocytic lymphohistiocytosis syndrome (HLS) may also revealed a PID. The objective of this study was to evaluate the occurrence of unknown PID in adult admitted in critical care unit and to determinate if the investigation of PID in patients with severe infections or HLS should be routinely performed in MCIU.
- Conditions
- Primary Immune Deficiency Disorder
- Being tested
- Internal Medicine consultation
- Keywords
- primary immunodeficiency, secondary immunodeficiency, intensive care unit, infection, adult
- Medical subject headings
- Primary Immunodeficiency Diseases, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internal Medicine consultationOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary objective : Number of patients with primary immune deficiency diagnosed after an admission in intensive care unit.
A consultation in the Internal Medicine department is schduled 3 months after the hospitalization in intensive care unit to investigate an immune deficiency. This consultation consit on a physical examination and a immune testing. Immune testing included but is not limited to :
Complete blood count, blood smear Immunoglobulin (Ig) isotype and IgG sub class quantitation (gram per litre) Quantitative serum complement (C3 (milligram per litre), C4 (milligram per litre), CH50 (%) and AP50 when Neisseria meningitides infection) Extensive immunophenotyping of T, B, and natural killer cells (cells/mm3) Specific antibody response to a variety of vaccine (milligram/litre) HIV serology Body computed tomography (CT) scan Lymphocytes, macrophage functional assays or genetic assay when necessary The outcome measure is the number of participants with abnormal laboratory or radiology values leading to primary immune deficiency diagnosis
Measured: A consultation in the Internal Medicine Department is scheduled 3 months after admission in intensive care unit
Secondary outcomes (1)
Secondary objectives : Number of patients diagnosed for a secondary immunodeficiency after admission in intensive care unit
A consultation in the Internal Medicine department is schduled 3 months after the hospitalization in intensive care unit to investigate an immune deficiency. This consultation consit on a physical examination and a immune testing. Immune testing included but is not limited to :
Complete blood count, blood smear Immunoglobulin (Ig) isotype and IgG sub class quantitation (gram per litre) Quantitative serum complement (C3 (milligram per litre), C4 (milligram per litre), CH50 (%) and AP50 when Neisseria meningitides infection) Extensive immunophenotyping of T, B, and natural killer cells (cells/mm3) Specific antibody response to a variety of vaccine (milligram/litre) HIV serology Body computed tomography (CT) scan Lymphocytes, macrophage functional assays or genetic assay when necessary The outcome measure is the number of participants with abnormal laboratory or radiology values leading to secondary immune deficiency diagnosis
Measured: A consultation in the Internal medicine department is scheduled 3 months after admisson in intensive care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study startJan 2015
- Primary completionJul 2017
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Immune Deficiency DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Prospective
- Enrolment
- 16 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas Martin Silva, MD, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02888535
- Sponsor's protocol ID
- 2014-A01246-41
- Acronym
- ICUSPID
- Status last verified
- Jul 2017
- First submitted
- 27 May 2016
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Care Unit and Secondary and Primary Immune Deficiency
- ClinicalTrials.gov ID
- NCT02888535
- Acronym / sponsor ID
- ICUSPID / 2014-A01246-41
- Conditions
- Primary Immune Deficiency Disorder
- Keywords
- primary immunodeficiency, secondary immunodeficiency, intensive care unit, infection, adult
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 5 Sep 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.
Primary immune deficiencies (PID) are characterized by a failure of the immune system that is not explained by any infectious, neoplastic, or iatrogenic cause. In 2015, more than 300 different inherited rare disorders were described. The occurrence of PID in adult is rare and diagnosis may be supported by the 6 ESID signs for adult. However these warnings signs are based only on expert recommendations and do not include comprehensive symptoms of PIDs. Recurrent infections, more aggressive, are the most common mode of revelation of the PID. Less frequently, autoimmune manifestation, solid tumor, lymphoproliferation tumor, chronic granulomatosis or hemophagocytic lymphohistiocytosis syndrome (HLS) may also revealed a PID. The objective of this study was to evaluate the occurrence of unknown PID in adult admitted in critical care unit and to determinate if the investigation of PID in patients with severe infections or HLS should be routinely performed in MCIU.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 to 65, hospitalized in medical intensive care unit for a severe or opportunistic infection or an idiopathic hemophagocytic syndrome, without any known warning sign or predisposing factor, were included.
Key inclusion criteria (6 listed)
- Aged 18-65
- Hospitalized in medical intensive care unit for :
- Severe infection without pathogen identification
- Severe infection due to encapsuled pathogen
- Opportunistic infections or unusual pathogen
Key exclusion criteria (3 listed)
- primary immunodeficiency already known
- secondary immunodeficiency already known (HIV, cancer, immunosuppressive or immunomodulatory treatment, nephrotic syndrome, protein-losing enteropathy, severe malnutrition before admission, cirrhosis with hepatic failure, sickle cell disease, splenectomy and moderate chronic renal failure (clearance between 30 and 59 m² min/1.73 ml)
- local-regional factors which can be responsible for infections (history of ear, nose and throat surgery or neurosurgery, history of fracture of the skull base, cystic fibrosis, chronic respiratory insufficient)
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 |
|---|---|---|
| Internal Medicine consultation | Other | – |
Primary outcome
Primary objective : Number of patients with primary immune deficiency diagnosed after an admission in intensive care unit.
Time frame: A consultation in the Internal Medicine Department is scheduled 3 months after admission in intensive care unit
A consultation in the Internal Medicine department is schduled 3 months after the hospitalization in intensive care unit to investigate an immune deficiency. This consultation consit on a physical examination and a immune testing. Immune testing included but is not limited to : Complete blood count, blood smear Immunoglobulin (Ig) isotype and IgG sub class quantitation (gram per litre) Quantitative serum complement (C3 (milligram per litre), C4 (milligram per litre), CH50 (%) and AP50 when Neisseria meningitides infection) Extensive immunophenotyping of T, B, and natural killer cells (cells/mm3) Specific antibody response to a variety of vaccine (milligram/litre) HIV serology Body computed tomography (CT) scan Lymphocytes, macrophage functional assays or genetic assay when necessary The outcome measure is the number of participants with abnormal laboratory or radiology values leading to primary immune deficiency diagnosis
1 secondary outcome
Secondary objectives : Number of patients diagnosed for a secondary immunodeficiency after admission in intensive care unit
Time frame: A consultation in the Internal medicine department is scheduled 3 months after admisson in intensive care unit
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 13 Feb 2023.
- Individual participant dataSharing planned: No
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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.
Nicolas Martin Silva, MD principal investigator
University Hospital, Caen
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 Immune Deficiency Disorder, run by University Hospital, Caen 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 6 inclusion and 3 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 13 Feb 2023. 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?
Primary objective : Number of patients with primary immune deficiency diagnosed after an admission in intensive care unit. (time frame: A consultation in the Internal Medicine Department is scheduled 3 months after admission in intensive care unit). 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 Feb 2023.