Identification and Characterization of Antibacterial Antibodies in Sera of Patients With Cystic Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Prevalence of antibacterial antibodies
研究概览
简要总结
Most of the cystic fibrosis (CF) patients are or have been pulmonary colonized with bacteria such as Pseudomonas aeruginosa or Staphylococcus aureus. Aim of this study is to detect virulence factor neutralizing antibodies in the sera of the study population followed by B cell repertoire analyses to design B cell-derived neutralizing monoclonal antibodies. The functionality of neutralizing antibodies rests on inhibition of virulence factors by binding of crucial epitopes rather than merely the induction of opsonization. Focusing on patients with bacterial colonization/chronic infections or a history of an acute infection in the past, will increase the likelihood for identification of serum with neutralizing activity as in vivo antigen contact is a prerequisite for antibody development and maturation. Since virulence factors are essential for infection, dissemination and tissue damage, inhibition of these factors by developed neutralizing antibodies might contribute to a favorable outcome of life-threatening infections.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years
- •Ability to give consent
- •Normal vital signs including:
- •Blood pressure systolic value 150 - 100 mmHg, diastolic value < 90 mmHg
- •Respiratory rate < 20/min
- •Oxygen saturation >92%
- •Heart rate 50 - 110/min
- •Body temperature <38°C
排除标准
- •Cytopenia (leukocytes < 1.500/µl, thrombocytes < 50.000/µl, Hemoglobin < 12 g/dl)
- •Heart disease or pulmonary hypertension
- •Body weight <50 kg (exclusion of blood sampling for B cell isolation)
- •Blood donation, larger blood loss and/or major surgery in the last 8 (male) or 12 (female) weeks
- •Any decline of the general state of health in the last 3 month including weight loss > 2kg, pulmonal exacerbation or increased impairment of pulmonary function (FEV1 < 50%)
结局指标
主要结局
Prevalence of antibacterial antibodies
时间窗: 3 years
次要结局
未报告次要终点
研究者
Alexander Simonis
MD
University of Cologne
