ENCAPSID Study : ENCApsulated Bacterial Infection and Primary, Secondary ImmunoDeficiency

NCT03721146 | Unknown DMC

• 1 other identifier: RCB 2018-A00079-46
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Immune Deficiency

Keywords

Encapsulated bacterial Infection; Primary immune deficiency; Secondary immune deficiency; Adult

Outcome Measures

Primary Outcomes (1)

• 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

  3 months

Secondary Outcomes (1)

• Number of patients diagnosed for a secondary immunodeficiency after admission for encapsulated bacterial infection

  3 months

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients admitted for an invasive encapsulated infection without predisposing factors

You may qualify if:

• Age :18 to 65 years old
• Admitted for an invasive encapsulated infection (Streptococcus pneumoniae, Streptococcus pyogènes, Haemophilus influenzae, Neisseiria meningitidis or Neisseria gonorrhoeae )

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Centre Hospitalier Universitaire Caen

Caen, 14000, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 10600329 BACKGROUND

Related Links

• French prevalence of primay immune deficiency
• European Society for immunodeficiency and warning signs for primary immune deficency

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Immunologic Deficiency Syndromes; Primary Immunodeficiency Diseases

Condition Hierarchy (Ancestors)

Immune System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Aurelie BALDOLLI, MD

  Infectious Diseases Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aurelie BALDOLLI, MD

CONTACT

+33681681986; baldolli-a@chu-caen.fr

Nicolas MARTIN SILVA, MD

CONTACT

+33231064718; martinsilva-n@chu-caen.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2018
• First Posted: October 26, 2018
• Study Start: September 1, 2018
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: December 4, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)