Season Surveillance Study of Viral Infections in Lung Transplant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 388
- 试验地点
- 1
- 主要终点
- Incidence of bronchiolitis obliterans syndrome
研究概览
简要总结
The present study was conducted to study the impact community acquired respiratory virus (CARV) infections in an outpatient setting on graft function of lung transplant recipients. The study was aimed to identify risk factors for CARV infections.
The study was further intended to investigate an association of Epstein-Barr virus (EBV), cytomegalovirus (CMV) and human adenovirus (HAdV) with the development of BOS and to identify risk factors for virus detection in blood.
详细描述
Informed consent was obtained from the LTx recipients and the study was approved of by the institutional review board of Hannover medical school.
LTx recipients are screened for CARV infections during the cold season (end October until end April) in a single-centre outpatient clinic. Symptoms of upper (URTI) and lower respiratory tract infections (URTI) are recorded by questionnaires and findings.
Nasopharyngeal and oropharyngeal swabs (NOS) were performed to detect RV-antigens by immunofluorescence testing (IFT) of respiratory-syncytial virus (RSV), adenovirus, parainfluenza (PIV), influenza and cultures for CARV are performed. BAL was performed when clinically indicated and processed by IFT. Multiplex-PCR to detect 14 CARV are processed in symptomatic patients.
In addition blood samples are monitored at each contact to investigate an association of Epstein-Barr virus (EBV), cytomegalovirus (CMV) and human adenovirus (HAdV) with the development of BOS and to identify risk factors for virus detection in blood.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults 18-70 years
- •lung transplantation (including single, double, combination and re-do transplants)
排除标准
- •refused consent
结局指标
主要结局
Incidence of bronchiolitis obliterans syndrome
时间窗: 1 year
次要结局
- Incidence of graft loss (death or re-do-transplantation)(2 year)
- Incidence of acute rejection(1 year)
- Incidence of hospitalisation(1 year)