ISRCTN10948363已完成不适用
Experimental Human Pneumococcal Carriage (Programme Grant) Research: working towards a nasal vaccine for pneumonia. The effect of age on immune function
iverpool School of Tropical Medicine0 个研究点目标入组 74 人开始时间: 2016年11月8日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •1. Adults (male or female) aged 50-84 years
- •2. Fluent spoken English - to ensure a comprehensive understanding of the research project and their proposed involvement
- •3. World Health Organisation performance status 0 (able to carry out all normal activity without restriction) or 1 (restricted in strenuous activity but ambulatory and able to carry out light work)
- •4. Access to telephone (safety and timely communication)
- •5. Capacity to give informed consent
排除标准
- •1. Close physical contact with at risk individuals (children under 5yrs, immunosuppressed adults) - minimise risk of pneumococcal transmission
- •2. History of drug or alcohol abuse (frequently drinking over the recommended alcohol intake limit: men and women should not regularly drink > 3-4 units/day and >2-3 units/day respectively) – minimise risk of pneumococcal disease
- •3. Smoking any cigarettes currently or within the last six months - minimise risk of pneumococcal disease
- •4. Ex-smoker with a significant smoking history (>10 pack years) – minimise risk of pneumococcal disease
- •5. Any current treatment for asthma – confounding effect of medications such as corticosteroids, and propensity to infection
- •6. Taking daily medications that may affect the immune system e.g. steroids, steroid nasal spray, antibiotics, disease modifying anti-rheumatoid drugs
- •7. Any acute illness (new symptoms within preceding 14 days which are unexplained by the known past medical history)
- •8. Having received any antibiotics in the preceding 28 days
- •9. Taking medication that affects blood clotting e.g. aspirin, clopidogrel, warfarin or other oral or injectable anticoagulants
- •10. History of culture-proven pneumococcal disease
- •11. Allergy to penicillin/amoxicillin
- •12. Involved in another clinical trial unless observational or in follow-up (non-interventional) phase.
- •13. Have been involved in a clinical trial involving EHPC and bacterial inoculation in the past three years
- •14. Significant cardiorespiratory disease (excluding stable hypertension)
- •15. Disease associated with altered immunity, including diabetes, alcohol abuse, malignancy, rheumatological conditions
- •16. Taking any medications except those on the allowed list”:statins; antihypertensives in stable hypertension; antidepressants; bisphosphonates; treatment for benign prostatic hyperplasia; hormone replacement therapy; vitamin supplements (including multivitamins, iron); anti-acid medications; nicotine replacement therapy (NRT)
研究者
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