SPAD in Adult Patients

NCT05664035 | Not Yet Recruiting

• 2 other identifiers: 2021_06992022-A00574-39
• Study Type: observational
• Target: 99
• Locations: 0 countries
• Sites: N/A

Brief Summary

The DETECT study aims to demonstrate the importance of detecting SPAD in adult patients with recurrent benign and/or severe unexplained bacterial upper/lower respiratory tract infections. Unlike children in whom the deficit may be transient, long-term strategies are warranted in SPAD adult patients to prevent severe infections and lung disability. Beyond the diagnosis of this still unrecognized PID in adult patients, we want to assess the impact of prophylactic antibiotics or IgRT on infections prevention and on quality of life in adult patients with the most severe clinical phenotypes, recurrent infections with high frequency of antibiotics take and/or recurrent infections with complications like bronchiectasis and/or severe infections requiring hospitalizations.

Conditions

Specific Antibody Deficiency; Predominantly Antibody Deficiencies

Keywords

Specific Antibody Deficiency; Predominant antibody deficiencies; Ig replacement therapy

Outcome Measures

Primary Outcomes (1)

• Diagnosis of SPAD according to the AAAAI proposed consensus criteria for an impaired selective response to PS using immunization with PPV23 and assessment of anti-PnPS IgG response by the serotype-specific WHO-standardized ELISA 4

  to 8 weeks after immunization

Secondary Outcomes (6)

• frequency of associated autoimmune or allergic diseases.

  Througth study completion, an average 24 months

• number of courses of antibiotics in the 12 months following IgRT start compared to the 12 months before IgRT

  Througth study completion, an average 24 months

• SF-36 questionnaire, number of missed work or school/university days in the 12 months following IgRT start compared to the 12 months before IgRT

  Througth study completion, an average 24 months

• frequency of courses of antibiotics in the 6 months following prophylaxis start compared to the 12 months before and/or number of patients switched to IgRT during the first 12 months.

  Througth study completion, an average 24 months

• SF-36 questionnaire, number of missed work or school/university days in the 12 months following prophylaxis start (or at the end of prophylactic antibiotics) compared to the 12 months before

  Througth study completion, an average 24 months

Study Arms (1)

Case group

18 to 65 year old patients with a history of recurrent bacterial infections of upper and/or lower respiratory tract for at least 2 years

Biological: Diagnosis of SPAD using immunization with PPV23

Interventions

Diagnosis of SPAD using immunization with PPV23 BIOLOGICAL

Diagnosis of SPAD using immunization with PPV23

Case group

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

Patients seen in Pneumology, Immunology, ENT or Infectious Diseases departments

You may qualify if:

• to 65 year old patients
• With a history of recurrent bacterial infections of upper and/or lower respiratory tract for at least 2 years, and fulfilling the specific following criteria:
• Normal serum IgG, IgA, IgM and IgG subclasses levels, normal CH50 and serum complement C3 and C4 proteins levels, normal T cells count
• Normal B cell count, normal serum protein electrophoresis and immunofixation. (\* excepted for Pseudomonas aeruginosa colonization)

You may not qualify if:

• Any general condition that predisposes to infections: solid or hematological malignancies, diabetes mellitus, severe alcohol or intravenous drug abuse, chronic liver or kidney failure, human immunodeficiency virus infection, anatomic or functional asplenia, drug-induced 1 neutropenia, or solid organ or hematopoietic stem cell transplantation;
• Any local predisposing factor to infections: cigarette smoking (\> 10 pack-year and/or 5 cigarettes/day), underlying infection (tuberculosis, influenza…), chronic obstructive pulmonary disease, oral, dental or skin conditions favorizing infections, streptococcal skin infections
• Pregnancy
• PPV23 administration in the last 2 years (risk of hyporesponsiveness)

Sponsors & Collaborators

• University Hospital, Lille: lead
• French Healthcare network for rare immune and hematological disorders (MARIH): collaborator
• Takeda: collaborator
• VitalAire: collaborator
• Laboratoire français de Fractionnement et de Biotechnologies: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Serum, peripheral blood mononuclear cells

Study Officials

• Guillaume LEFEVRE, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guillaume LEFEVRE, MD,PhD

CONTACT

0320445962; guillaume.lefevre@chu-lille.fr

Study Design

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

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: December 23, 2022
• Study Start: March 1, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 23, 2022

Record last verified: 2022-12