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临床试验/ISRCTN12884329
ISRCTN12884329已完成未知

The PneumEx study: experimental human pneumococcal challenge and exhaled pneumococcal biomarkers

iverpool School of Tropical Medicine0 个研究点目标入组 41 人开始时间: 2019年8月30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
41

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

性别
All

入选标准

  • 1. Adults aged 18-50 years
  • 2. Fluent spoken English
  • 3. Access to mobile telephone – to ensure safety and timely communication
  • 4. Capacity to give informed consent

排除标准

  • 1. Research participant:
  • 1.1. Currently involved in another study unless observational or non-interventional except for the EHPC bronchoscopy study
  • 1.2. Participant in a previous EHPC trial within the last 3 years (at the discretion of the study team, i.e. not inoculated nasally with pneumococcus)
  • 2. Vaccination: previous pneumococcal vaccination PPV23 or PCV13 (routine in UK babies born since 2005 or US 2001)
  • 3. Allergy: to penicillin/amoxicillin and clarithromycin (or other macrolides)
  • 4. Health history:
  • 4.1. Chronic ill health including immunosuppressive history, diabetes, asthma (on regular medication), recurrent otitis media or other respiratory disease
  • 4.2. Medication that may affect the immune system e.g. steroids, inflammation altering (e.g. nasal steroids, roacutane) or disease-modifying anti-rheumatoid drugs.
  • 4.3. Recent antibiotics (within the last 28 days or long term for known active chronic infection)
  • 4.4. Current illness or acute illness within 14 days prior to inoculation
  • 4.5. Major pneumococcal illness requiring hospitalisation
  • 4.6. Other conditions considered by the clinical team as a concern for participant safety or integrity of the study
  • 5. Direct caring role or close contact: with individuals at higher risk of infection:
  • 5.1. Children under 5 years age
  • 5.2. Chronic ill health or immunosuppressed adults
  • 6. Smoker:
  • 6.1. Current or ex-smoker (regular cigarettes, regular e-cigarette/vaping and regular smoking of recreational drugs) in the last 6 months
  • 6.2. Previous significant smoking history - more than 20 cigarettes per day for 20 years or the equivalent (>20 pack years)
  • 7. Women of childbearing potential (WOCBP): who are:
  • 7.1. Not deemed to have sufficient/effective birth control or confirmed abstinence
  • 7.2. Pregnant
  • 8. History or current drug or alcohol abuse: (frequently drinking alcohol: men and women should not regularly drink >3 units/day and >2 units/day respectively) at the discretion of the clinician
  • 9. Overseas travel planned in the follow-up period of the study visits

研究者

发起方
iverpool School of Tropical Medicine

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