Frequency of SPAD in Adult Patients (DETECT)

Detection of Specific Polysaccharide Antibody Deficiency in Adult Patients With Unexplained Recurrent and/or Severe Bacterial Infections

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, the investigators 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.

Study Overview

• Status: Recruiting
• Conditions: Specific Antibody Deficiency; Predominantly Antibody Deficiencies
• Intervention / Treatment: Biological: Diagnosis of SPAD using immunization with PPV23

Detailed Description

This multicenter observational prospective study will be conducted in 15 university or general hospitals, mostly centers included in the national network of the reference center CEREDIH. Pulmonologists, clinical immunologists and ENT specialists will be solicited in each center to refer patients for inclusions.

All patients who fulfill eligibility criteria will be tested for anti-pneumococcal polysaccharides (PnPSs) response with the 23-valent pneumococcal (unconjugated) vaccine (PPV23) (V1, Day 0: blood sample anti-PnPS antibodies, and immunization; V2, Day 28-56): blood sample for anti-PnPS antibodies).

If a SPAD would be diagnosed, the investigator will be free to consider prophylactic antibiotics and/or IgRT according to the medical history of the patient (notably in case of persistent infections while using prophylactic antibiotics). The efficiency on infections prevention and the impact on health-related quality of life (HRQoL) will be assessed 12 months after initiation of IgRT or prophylactic antibiotics (Visit 3).

• Study Type: Observational
• Enrollment (Estimated): 99

Contacts and Locations

• Study Contact: Name: Guillaume LEFEVRE, MD,PhD; Phone Number: +33 0320445962; Email: guillaume.lefevre@chu-lille.fr

Study Locations

• France
  • Lille, France, 59037
    • Recruiting
    • Lille University Hospital
    • Principal Investigator: GUILLAUME LEFEVRE, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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, and fulfilling the specific following criteria:
• Recurrent benign infections currently requiring 6 courses of antibiotics /year or more, or Bilateral bronchiectasis/bronchiolitis (after exclusion of cystic fibrosis and ciliary dyskinesia) AND recurrent benign infections currently requiring 3 courses of antibiotics /year or more or A history of severe upper/lower respiratory tract bacterial infection, and/or invasive infection with Streptococcus pneumonia, Streptococcus pyogenes or Haemophilus influenzae, which required hospitalization in the last 2 years, AND recurrent benign infections currently requiring 3 courses of antibiotics /year.
• 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)

Exclusion Criteria:

• 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
• Any other SID or PID diagnosed before inclusion
• Pregnancy
• PPV23 administration in the last 2 years (risk of hyporesponsiveness)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Diagnosis of SPAD using immunization with PPV23

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the frequency of SPAD in adult patients with unexplained recurrent bacterial respiratory infections	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	4 to 8 weeks after immunization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To describe infectious and non infectious associated diseases, including allergy and autoimmune diseases, in SPAD patients.		Througth study completion, an average 24 months
To assess the benefit of IgRT on the frequency of courses of antibiotic therapy.	Outcome measure: 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
To assess the benefit of IgRT on QoL and daily life.	Outcome measure: 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
To assess the benefit of prophylactic antibiotics on the frequency of courses of antibiotic therapy.	Outcome measure: 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
To assess the benefit of prophylactic antibiotics on QoL and daily life.	Outcome measure: 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
To collect serum and mononuclear cells for future research projects in SPAD and undiagnosed patients.	To collect serum and mononuclear cells for future research projects in SPAD and undiagnosed patients	Througth study completion, an average 24 months

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: Takeda; Laboratoire français de Fractionnement et de Biotechnologies; VitalAire; French Healthcare network for rare immune and hematological disorders (MARIH)
• Investigators: Principal Investigator: Guillaume LEFEVRE, MD,PhD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: December 15, 2022
• First Submitted That Met QC Criteria: December 15, 2022
• First Posted (Actual): December 23, 2022

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Specific Antibody Deficiency; Predominant antibody deficiencies; Ig replacement therapy
• Other Study ID Numbers: 2021_0699; 2022-A00574-39 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No