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.
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
99
Diagnosis of SPAD using immunization with PPV23
Lille University Hospital
Lille, France
RECRUITINGTo 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
Time frame: 4 to 8 weeks after immunization
To describe infectious and non infectious associated diseases, including allergy and autoimmune diseases, in SPAD patients.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Througth study completion, an average 24 months
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