Immune DeficiencyENCAPSIDNCT03721146
ENCAPSID Study : ENCApsulated Bacterial Infection and Primary, Secondary ImmunoDeficiency
An observational study of Immune Deficiency, run by University Hospital, Caen at 1 site in France.
Trial summary
Background : The occurrence of Primary immune deficiencies (PID) is rare in adults. Antibody deficiencies were the first PID to be diagnosed in adulthood and are mainly represented by common variable immune deficiency. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Immune Deficiency
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2018to 1 Sep 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients admitted for an invasive encapsulated infection without predisposing factors
Who may be able to join
- Age :18 to 65 years old
- Admitted for an invasive encapsulated infection (Streptococcus pneumoniae, Streptococcus pyogènes, Haemophilus influenzae, Neisseiria meningitidis or Neisseria gonorrhoeae )
Who cannot join
- Medical history of PID
- Medical history of Secondary immune deficiency (SID)
- A local-regional factor that could predispose them to infection (chronic pulmonary failure, cystic fibrosis, base scull fracture....)
- An hospital-acquired infection
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire Caen
Caen, 14000
Aurelie BALDOLLI, MD, +33681681986, baldolli-a@chu-caen.fr
Nicolas MARTIN SILVA, MD, +33231064718, martinsilva-n@chu-caen.fr
About this study
Official title: ENCAPSID Study : Encapsulated Bacterial Infection and Primary, Secondary Immunodeficiency
Background : The occurrence of Primary immune deficiencies (PID) is rare in adults. Antibody deficiencies were the first PID to be diagnosed in adulthood and are mainly represented by common variable immune deficiency. The main manifestation of these PID are encapsulated bacterial infection which used to be recurrent and/or invasive, lead to hospitalization and have high rates of morbidity and mortality. Diagnosis of PID in adulthood may be supported by six warning signs from the European Society of Immunodeficiencies (ESID). However, their guidelines do not comprehensively describe symptoms of PID, even for patients with infections. The guidelines recommend screening adults for PID after at least two severe bacterial infections. The aim of this study is to screen for PID adult admitted to our hospital for encapsulated infection without any predisposal factor.
Material and methods :
Read more
- Monocentric study. Inclusion between September 218 and September 2021
- Inclusion criteria :
- Age 18 to 65 years old
- Invasive encapsulated infection (Streptococcus pneumoniae, Streptococcus pyogènes, Haemophilus influenzae, Neisseiria meningitidis or Neisseria gonorrhoeae )
- Exclusion criteria :
- Medical history of PID
- Medical history of Secondary immune deficiency (SID)
- Local-regional factor that could predispose them to infection
- Hospital-acquired infection
- PID screening included the following: complete blood count, blood smear, immunoglobulin (Ig) isotype (IgA,M, G) and IgG subclass levels, total hemolytic complement and complement fractions (C) 3 and 4, alternative complement pathway (AP50) in case of Neisseria meningitidis (NM) infection, quantitative immunophenotyping of T, B and natural killer cells, specific antibody response to diphtheria, tetanus and pneumococcal vaccine and HIV serology. The clinical and laboratory diagnostic criteria used to identify PID were based on guidelines from the ESID and the Pan-American Group for Immunodeficiency (PAGID)
- A consultation in the infectious Diseases Department or Internal Medicine will be scheduled the hospitalization 3 months later to include patients and perform PID screening.
Read the detailed description
Background : Primary immune deficiencies (PID) are characterized by a failure of the immune system that is not explained by any infectious, neoplastic, or iatrogenic causes. By 2017, more than 350 different inherited rare PID disorders had been described. The occurrence of PID is rare in adults, with a prevalence of approximately 6.7 per 100,000 inhabitants in France. Infections are the most common manifestations of PID .Theses Infections are usually recurrent and/or invasive, lead to hospitalization and have high rates of morbidity and mortality. Antibody deficiencies were the first PID to be diagnosed in adulthood and are mainly represented by common variable immune deficiency. The main manifestation of these PID are encapsulated bacterial infection. Diagnosis of PID in adulthood may be supported by six warning signs from the European Society of Immunodeficiencies (ESID). However, their guidelines do not comprehensively describe symptoms of PID, even for patients with infections. The guidelines recommend screening adults for PID after at least two severe bacterial infections. The aim of this study is to screen for PID adult admitted to our hospital for encapsulated infection without any predisposal factor.
Material and methods :
- Monocentric study. Inclusion between September 218 and September 2021
- Every months, micriobiologists will transfer to infectious diseases doctors and internal medicine doctors the name of patients who had a sample (cerebral fluid, articular fluid, blood culture, urine culture...) positive for Streptococcus pneumoniae, Streptococcus pyogenes, Haemophilus influenzae, Neisseiria meningitidis or Neisseria gonorrhoeae.
- Doctors will look at their medical records to see if they are eligible.
- Inclusion criteria :
- Age 18 to 65 years old
- Invasive encapsulated infection (Streptococcus pneumoniae, Streptococcus pyogènes, Haemophilus influenzae, Neisseiria meningitidis or Neisseria gonorrhoeae )
- Exclusion criteria :
- Medical history of PID
- Medical history of Secondary immune deficiency (SID)
- Local-regional factor that could predispose them to infection
- Hospital-acquired infection If patients are eligible, a consultation in the infectious Diseases Department or Internal Médicine Department will be scheduled the hospitalization 3 months later to include patients and perform PID screening.
- PID screening included the following: complete blood count, blood smear, immunoglobulin (Ig) isotype (IgA,M, G) and IgG subclass levels, total hemolytic complement and complement fractions (C) 3 and 4, alternative complement pathway (AP50) in case of Neisseria meningitidis (NM) infection, quantitative immunophenotyping of T, B and natural killer cells, specific antibody response to diphtheria, tetanus and pneumococcal vaccine and HIV serology. The clinical and laboratory diagnostic criteria used to identify PID were based on guidelines from the ESID and the Pan-American Group for Immunodeficiency (PAGID)
- Conditions
- Immune Deficiency
- Keywords
- Encapsulated bacterial Infection, Primary immune deficiency, Secondary immune deficiency, Adult
- Medical subject headings
- Immunologic Deficiency Syndromes, Primary Immunodeficiency Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients diagnosed for a primary immunodeficiency after admission for encapsulated bacterial infection
A consultation in the Internal Medicine or Infectious Diseases Department is scheduled 3 months after admission at the hospital for encapsulated bacterial infection 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. The outcome measure is the number of participants with abnormal laboratory or radiology values leading to primary immune deficiency diagnosis
Measured: 3 months
Secondary outcomes (1)
Number of patients diagnosed for a secondary immunodeficiency after admission for encapsulated bacterial infection
A consultation in the Internal Medicine or Infectious Diseases Department is scheduled 3 months after admission at the hospital for encapsulated bacterial infection 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. The outcome measure is the number of participants with abnormal laboratory or radiology values leading to secondary immune deficiency diagnosis
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study start1 Sep 2018
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
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 Immune DeficiencyStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aurelie BALDOLLI, MD, Principal investigator, Infectious Diseases Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03721146
- Sponsor's protocol ID
- RCB 2018-A00079-46
- Acronym
- ENCAPSID
- Status last verified
- Oct 2018
- First submitted
- 22 Oct 2018
- Last updated
- 4 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Conley ME, Notarangelo LD, Etzioni A. Diagnostic criteria for primary immunodeficiencies. Representing PAGID (Pan-American Group for Immunodeficiency) and ESID (European Society for Immunodeficiencies). Clin Immunol. 1999 Dec;93(3):190-7. doi: 10.1006/clim.1999.4799. No abstract available.
PubMed 10600329
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ENCAPSID Study : Encapsulated Bacterial Infection and Primary, Secondary Immunodeficiency
- ClinicalTrials.gov ID
- NCT03721146
- Acronym / sponsor ID
- ENCAPSID / RCB 2018-A00079-46
- Conditions
- Immune Deficiency
- Keywords
- Encapsulated bacterial Infection, Primary immune deficiency, Secondary immune deficiency, Adult
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 26 Oct 2018 (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.
Background : The occurrence of Primary immune deficiencies (PID) is rare in adults. Antibody deficiencies were the first PID to be diagnosed in adulthood and are mainly represented by common variable immune deficiency. The main manifestation of these PID are encapsulated bacterial infection which used to be recurrent and/or invasive, lead to hospitalization and have high rates of morbidity and mortality. Diagnosis of PID in adulthood may be supported by six warning signs from the European Society of Immunodeficiencies (ESID). However, their guidelines do not comprehensively describe symptoms of PID, even for patients with infections. The guidelines recommend screening adults for PID after at least two severe bacterial infections. The aim of this study is to screen for PID adult admitted to our hospital for encapsulated infection without any predisposal factor.
Material and methods :
- Monocentric study. Inclusion between September 218 and September 2021
- Inclusion criteria :
- Age 18 to 65 years old
- Invasive encapsulated infection (Streptococcus pneumoniae, Streptococcus pyogènes, Haemophilus influenzae, Neisseiria meningitidis or Neisseria gonorrhoeae )
- Exclusion criteria :
- Medical history of PID
- Medical history of Secondary immune deficiency (SID)
- Local-regional factor that could predispose them to infection
- Hospital-acquired infection
- PID screening included the following: complete blood count, blood smear, immunoglobulin (Ig) isotype (IgA,M, G) and IgG subclass levels, total hemolytic complement and complement fractions (C) 3 and 4, alternative complement pathway (AP50) in case of Neisseria meningitidis (NM) infection, quantitative immunophenotyping of T, B and natural killer cells, specific antibody response to diphtheria, tetanus and pneumococcal vaccine and HIV serology. The clinical and laboratory diagnostic criteria used to identify PID were based on guidelines from the ESID and the Pan-American Group for Immunodeficiency (PAGID)
- A consultation in the infectious Diseases Department or Internal Medicine will be scheduled the hospitalization 3 months later to include patients and perform PID screening.
Detailed description
Background : Primary immune deficiencies (PID) are characterized by a failure of the immune system that is not explained by any infectious, neoplastic, or iatrogenic causes. By 2017, more than 350 different inherited rare PID disorders had been described. The occurrence of PID is rare in adults, with a prevalence of approximately 6.7 per 100,000 inhabitants in France. Infections are the most common manifestations of PID .Theses Infections are usually recurrent and/or invasive, lead to hospitalization and have high rates of morbidity and mortality. Antibody deficiencies were the first PID to be diagnosed in adulthood and are mainly represented by common variable immune deficiency. The main manifestation of these PID are encapsulated bacterial infection. Diagnosis of PID in adulthood may be supported by six warning signs from the European Society of Immunodeficiencies (ESID). However, their guidelines do not comprehensively describe symptoms of PID, even for patients with infections. The guidelines recommend screening adults for PID after at least two severe bacterial infections. The aim of this study is to screen for PID adult admitted to our hospital for encapsulated infection without any predisposal factor.
Material and methods :
- Monocentric study. Inclusion between September 218 and September 2021
- Every months, micriobiologists will transfer to infectious diseases doctors and internal medicine doctors the name of patients who had a sample (cerebral fluid, articular fluid, blood culture, urine culture...) positive for Streptococcus pneumoniae, Streptococcus pyogenes, Haemophilus influenzae, Neisseiria meningitidis or Neisseria gonorrhoeae.
- Doctors will look at their medical records to see if they are eligible.
- Inclusion criteria :
- Age 18 to 65 years old
- Invasive encapsulated infection (Streptococcus pneumoniae, Streptococcus pyogènes, Haemophilus influenzae, Neisseiria meningitidis or Neisseria gonorrhoeae )
- Exclusion criteria :
- Medical history of PID
- Medical history of Secondary immune deficiency (SID)
- Local-regional factor that could predispose them to infection
- Hospital-acquired infection If patients are eligible, a consultation in the infectious Diseases Department or Internal Médicine Department will be scheduled the hospitalization 3 months later to include patients and perform PID screening.
- PID screening included the following: complete blood count, blood smear, immunoglobulin (Ig) isotype (IgA,M, G) and IgG subclass levels, total hemolytic complement and complement fractions (C) 3 and 4, alternative complement pathway (AP50) in case of Neisseria meningitidis (NM) infection, quantitative immunophenotyping of T, B and natural killer cells, specific antibody response to diphtheria, tetanus and pneumococcal vaccine and HIV serology. The clinical and laboratory diagnostic criteria used to identify PID were based on guidelines from the ESID and the Pan-American Group for Immunodeficiency (PAGID)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted for an invasive encapsulated infection without predisposing factors
Key inclusion criteria (2 listed)
- Age :18 to 65 years old
- Admitted for an invasive encapsulated infection (Streptococcus pneumoniae, Streptococcus pyogènes, Haemophilus influenzae, Neisseiria meningitidis or Neisseria gonorrhoeae )
Key exclusion criteria (4 listed)
- Medical history of PID
- Medical history of Secondary immune deficiency (SID)
- A local-regional factor that could predispose them to infection (chronic pulmonary failure, cystic fibrosis, base scull fracture....)
- An hospital-acquired 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
Number of patients diagnosed for a primary immunodeficiency after admission for encapsulated bacterial infection
Time frame: 3 months
A consultation in the Internal Medicine or Infectious Diseases Department is scheduled 3 months after admission at the hospital for encapsulated bacterial infection 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. The outcome measure is the number of participants with abnormal laboratory or radiology values leading to primary immune deficiency diagnosis
1 secondary outcome
Number of patients diagnosed for a secondary immunodeficiency after admission for encapsulated bacterial infection
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2018.
- Background: PubMed 10600329Conley ME, Notarangelo LD, Etzioni A. Diagnostic criteria for primary immunodeficiencies. Representing PAGID (Pan-American Group for Immunodeficiency) and ESID (European Society for Immunodeficiencies). Clin Immunol. 1999 Dec;93(3):190-7. doi: 10.1006/clim.1999.4799. No abstract available.
- French prevalence of primay immune deficiencyLink provided by the sponsor.
- European Society for immunodeficiency and warning signs for primary immune deficencyLink provided by the sponsor.
- 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.
Aurelie BALDOLLI, MD principal investigator
Infectious Diseases Department
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 Immune Deficiency, 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 2 inclusion and 4 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 4 Dec 2018. 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 Aurelie BALDOLLI, MD (+33681681986, baldolli-a@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients diagnosed for a primary immunodeficiency after admission for encapsulated bacterial infection (time frame: 3 months). 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 NCT03721146, 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 4 Dec 2018.