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
相似试验
进行中（未招募）
Unknown
A pneumococcal human challenge study in adults aged 50-84 yearsPneumoccocal carriageInfections and InfestationsISRCTN71362981iverpool School of Tropical Medicine15
已完成
不适用
Experimental human Pneumococcal carriage: Aging and immunityISRCTN10948363iverpool School of Tropical Medicine74
暂停
不适用
Experimental human pneumococcal challenge in chronic obstructive pulmonary disease and cigarette smokingStreptococcus pneumoniae infection in smokers and people with chronic obstructive pulmonary disease (COPD)Infections and InfestationsISRCTN75415747iverpool School of Tropical Medicine (LSTM)70
已完成
不适用
A controlled human pneumococcal infection modelnasal carriage of Streptococcus pneumoniaepneumococcal infection10004018NL-OMON51807Radboud Universitair Medisch Centrum20
已完成
不适用
Experimental Human Pneumococcal Carriage Model Testing New StrainsSpecialty: Infectious diseases and microbiology, Primary sub-specialty: Antimicrobial ResearchUKCRC code/ Disease: Infection/ Bacterial, viral and other infectious agentsInfections and InfestationsInfection/ Bacterial, viral and other infectious agentsISRCTN68323432Royal Liverpool and Broadgreen University Hospitals134