NL-OMON42371尚未招募不适用
The effects of preceding human endotoxemia on the Fluenz-induced immune response, a explorative study - LPS-Fluenz
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99(—)
入选标准
- •Age >=18 and <=35 years of age
排除标准
- •-Pre-existent lung disease, including asthma
- •-A history of allergic rhinitis
- •-Use of any medication
- •-Use of alcohol > 5/day or >20/wk
- •-Use of any drugs
- •-Current smoker or more than 5 pack-year history
- •-Frequently have nosebleeds
- •-Recent nasal or otologic surgery
- •-Febrile illness or a common cold within four weeks before the LPS challenge
- •-Currently participating in another clinical trial or donation of blood 3 months prior to the LPS challenge.
- •-Previous spontaneous vagal collapse.
- •-History, signs or symptoms of cardiovascular disease.
- •-(Family) history of myocardial infarction or stroke under the age of 65 years.
- •-Cardiac conduction abnormalities on the ECG consisting of a 2nd degree atrioventricular block or a
- •complex bundle branch block.
- •-Hypertension (defined as RR systolic > 160 or RR diastolic > 90).
- •-Hypotension (defined as RR systolic < 100 or RR diastolic < 50).
- •-Renal impairment (defined as plasma creatinin >120 µmol/l).
- •-Liver enzyme abnormalities or positive hepatitis serology.
- •-Positive HIV serology or medical history of any other obvious disease associated with immune deficiency.
- •-History of allergic reaction to Fluenz®, eggs / gelatin / gentamicin
- •-History of Guillain-Barré Syndrome
研究者
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