Detection of Specific Polysaccharide Antibody Deficiency in Adult Patients With Unexplained Recurrent and/or Severe Bacterial Infections
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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)
结局指标
主要结局
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
时间窗: to 8 weeks after immunization
次要结局
- Biological collection(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)
- 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)
- 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)
- 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)
- frequency of associated autoimmune or allergic diseases.(Througth study completion, an average 24 months)