成年患者的 SPAD (DETECT)
不明原因复发和/或严重细菌感染成年患者特异性多糖抗体缺乏症的检测
研究概览
详细说明
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).
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Guillaume LEFEVRE, MD,PhD
- 电话号码：+33 0320445962
- 邮箱：guillaume.lefevre@chu-lille.fr
学习地点
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Lille、法国、59037
- 招聘中
- Lille University Hospital
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首席研究员：
- GUILLAUME LEFEVRE, MD, PhD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
取样方法
研究人群
描述
纳入标准：
- 18至65岁患者
- 具有上呼吸道和/或下呼吸道反复细菌感染病史至少2年，并满足以下具体标准：
- 目前需要 6 个疗程抗生素/年或以上的复发性良性感染，或双侧支气管扩张/细支气管炎（排除囊性纤维化和纤毛运动障碍后）和目前需要 3 个疗程抗生素/年或以上的复发性良性感染或有严重的上/下呼吸道细菌感染，和/或肺炎链球菌、化脓性链球菌或流感嗜血杆菌的侵袭性感染，在过去 2 年内需要住院治疗，并且复发性良性感染目前需要 3 个疗程的抗生素/年。
- 正常血清 IgG、IgA、IgM 和 IgG 亚类水平，正常 CH50 和血清补体 C3 和 C4 蛋白水平，正常 T 细胞计数
- B 细胞计数正常，血清蛋白电泳和免疫固定正常。 （* 铜绿假单胞菌定植除外）
排除标准：
- 任何易于感染的一般情况：实体或血液恶性肿瘤、糖尿病、严重酒精或静脉药物滥用、慢性肝或肾功能衰竭、人类免疫缺陷病毒感染、解剖性或功能性无脾、药物引起的 1 中性粒细胞减少症，或实体器官或造血功能障碍干细胞移植；
- 任何局部感染易感因素：吸烟（> 10 包年和/或 5 支香烟/天）、潜在感染（肺结核、流感……）、慢性阻塞性肺病、口腔、牙齿或皮肤状况有利于感染、链球菌皮肤感染
- 纳入前诊断出的任何其他 SID 或 PID
- 怀孕
- 在过去 2 年中使用 PPV23（反应性低下的风险）
学习计划
研究是如何设计的？
设计细节
- 观测模型：仅案例
- 时间观点：预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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个案组
18至65岁，有至少2年以上和/或下呼吸道反复细菌感染病史的患者
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使用 PPV23 免疫诊断 SPAD
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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To assess the frequency of SPAD in adult patients with unexplained recurrent bacterial respiratory infections
大体时间：4 to 8 weeks after immunization
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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
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4 to 8 weeks after immunization
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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To describe infectious and non infectious associated diseases, including allergy and autoimmune diseases, in SPAD patients.
大体时间：Througth study completion, an average 24 months
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Througth study completion, an average 24 months
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To assess the benefit of IgRT on the frequency of courses of antibiotic therapy.
大体时间：Througth study completion, an average 24 months
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Outcome measure: number of courses of antibiotics in the 12 months following IgRT start compared to the 12 months before IgRT
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Througth study completion, an average 24 months
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To assess the benefit of IgRT on QoL and daily life.
大体时间：Througth study completion, an average 24 months
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Outcome measure: number of missed work or school/university days in the 12 months following IgRT start compared to the 12 months before IgRT
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Througth study completion, an average 24 months
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To assess the benefit of prophylactic antibiotics on the frequency of courses of antibiotic therapy.
大体时间：Througth study completion, an average 24 months
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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.
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Througth study completion, an average 24 months
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To assess the benefit of prophylactic antibiotics on QoL and daily life.
大体时间：Througth study completion, an average 24 months
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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.
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Througth study completion, an average 24 months
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To collect serum and mononuclear cells for future research projects in SPAD and undiagnosed patients.
大体时间：Througth study completion, an average 24 months
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To collect serum and mononuclear cells for future research projects in SPAD and undiagnosed patients
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Througth study completion, an average 24 months
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合作者和调查者
合作者
调查人员
- 首席研究员：Guillaume LEFEVRE, MD,PhD、University Hospital, Lille
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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