ISRCTN85509051已完成未知
Early and late nasal and tonsil cell responses during human pneumococcal colonisation
iverpool School of Tropical Medicine0 个研究点目标入组 20 人开始时间: 2017年7月11日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
2019 Results article in https://pubmed.ncbi.nlm.nih.gov/31361601/ (added 05/09/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Have capacity to give informed consent
- •2. Aged 18-50 years (ages chosen to minimise discrepancy in the immune response and to minimise the risk of pneumococcal disease)
- •3. Speak fluent English (to ensure a comprehensive understanding of the research project and their proposed involvement, in order to minimise any communication issues to maximize participant safety)
- •1. Have capacity to give informed consent
- •2. Aged 18-50 years (ages chosen to minimise discrepancy in the immune response and to minimise the risk of pneumococcal disease)
- •3. Speak fluent English (to ensure a comprehensive understanding of the research project and their proposed involvement, in order to minimise any communication issues to maximize participant safety)
- •4. Consented for elective nasal septum and or turbinate surgery
排除标准
- •Stage One-Optimization group
- •1. Chronic rhinosinusitis (CRS) with or without nasal polypoidal disease
- •2. Use of oral of nasal steroid spray up to the day of surgery
- •3. Currently involved in another study unless observational or in follow-up phase (non-interventional)
- •1. Currently involved in another study unless observational or in follow-up phase (non-interventional)
- •2. Close contact with at risk individuals (children under 5 years, immunosuppressed adults, elderly, chronic ill health) – to minimise risk of pneumococcal transmission
- •3. Current regular smoker (smokes daily) or previous regular smoker that has stopped smoking less than 12 months ago (< 10 years).
- •4. Asthma or respiratory disease – to minimise risk of pneumococcal disease
- •5. Current acute or chronic rhinosinusitis with or without nasal polypoidal disease
- •6. Pregnant - to minimise the risk of pneumococcal disease
- •7. Allergic to penicillin or amoxicillin
- •8. Allergic to local anaesthetic
- •9. On medication that may affect the immune system in any way e.g. steroids
- •10. Been involved in a clinical trial involving EHPC over the last 3 years
- •11. Current acute severe febrile illness
- •12. Taking long term antibiotics
- •13. On oral anti-platelets or warfarin therapy
- •1. Currently involved in another study unless observational or in follow-up phase (non-interventional)
- •2. Close contact with at risk individuals (children under 5 years, immunosuppressed adults, elderly, chronic ill health) – to minimise risk of pneumococcal transmission
- •3. Current regular smoker (smokes daily) or previous regular smoker that has stopped smoking less than 12 months ago (< 10 years).
- •4. Asthma or respiratory disease – to minimise risk of pneumococcal disease
- •5. Current acute or chronic rhinosinusitis with or without nasal polypoidal disease
- •6. Pregnant - to minimise the risk of pneumococcal disease
- •7. Allergic to penicillin or amoxicillin
- •8. On medication that may affect the immune system in any way e.g. steroids,
- •9. Been involved in a clinical trial involving EHPC over the last 3 years
- •10. Current acute severe febrile illness
- •11. Taking long term antibiotics
- •12. Previous tonsillectomy
- •*Participants that have been started on nasal steroid spray to relive the nasal blockage symptoms will be advised to stop **Participants in Group 2 on oral anti-platelets therapy of warfarin are advised to stop the medication up to seven days prior to their elective nasal surgery and additional nasal and tonsillar biopsy to minimise the risk of bleeding as per the pre-operative assessment clinic advise.
研究者
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