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临床试验/NCT04700358
NCT04700358招募中不适用

Identification and Characterization of Antibacterial Antibodies in Sera of Patients With Cystic Fibrosis

University Hospital of Cologne1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2020年10月1日最近更新:
适应症

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

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

发起方
University Hospital of Cologne
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alexander Simonis

MD

University of Cologne

研究点 (1)

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