ISRCTN12036902进行中（未招募）Unknown
nderstanding how two common respiratory infections interact in the nose of healthy adults: Respiratory Syncytial Virus and Streptococcus pneumoniae
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 入组人数
- 113
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. Healthy adults aged 18-55 years (inclusive, at the time of consent)
- •2. Fluent spoken English – to ensure a comprehensive understanding of the research project
- •3. Capacity to provide written informed consent in English
- •4. Females of childbearing potential with a negative urine pregnancy test at screening and willing to practice adequate contraceptive measures as per UK Clinical Trial Facilitation Group during the study.
- •5. Willing to provide their household contacts with the Close Contact Screening Information Letter
- •6. For Phase C, RSV neutralising antibody titre in the lowest 10th percentile of screened participants
排除标准
- •1. Research participant:
- •1.1. Currently involved in another study unless observational or non-interventional. Exceptions may be applied at the discretion of the Chief Investigator to ensure no harm comes to the participants (e.g. excessive blood sampling or nasal sampling)
- •1.2. Participated in a previous Spn6B EHPC study < = 3 years or an Spn3 EHPC study < = 1 year before screening
- •2. Unable to travel to outpatient clinic for visits without using public transport
- •3. Unable to wear an FFP2 mask
- •4. Nasal carriage: Participants who have natural pneumococcal or RSV-A nasal carriage identified at visit 1 will be excluded before randomisation (see table 2A).
- •5. Vaccination:
- •5.1. No live vaccination within four weeks prior to enrolment (defined as time of first inoculation)
- •5.2. Previous pneumococcal or (investigational) RSV vaccination (including in a research study)
- •6. Allergy to beta-lactam antibiotics (including penicillin and amoxicillin)
- •7. Medical history leading to increased risk of severe infection, illness including but not limited to:
- •7.1. Asplenia or dysfunction of the spleen
- •7.2. Chronic respiratory disease (e.g. asthma [requiring medication (including salbutamol inhaler) within last 12 months], COPD, bronchiectasis and sleep apnoea)
- •7.3. Chronic heart disease (e.g. angina, ischaemic heart disease, chronic heart failure) – controlled and stable hypertension may be included
- •7.4. Chronic kidney disease (e.g. nephrotic syndrome, kidney transplant, requires dialysis)
- •7.5. Chronic liver disease (e.g. cirrhosis, biliary atresia, hepatitis)
- •7.6. Chronic neurological disease that limits mobility, bulbar or respiratory function (including stroke, Parkinson’s disease, dementia and multiple sclerosis)
- •7.7. Diabetes mellitus (including diet controlled)
- •7.8. Receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 12 months or long-term systemic corticosteroid, Roaccutane, or disease modifying anti-rheumatoid drugs therapy (for more than 7 consecutive days within the 3 months prior to enrolment).
- •7.9. Individuals with cochlear ear implants
- •7.10. Individuals with major cerebrospinal fluid leaks (e.g. following traumatic, major skull surgery, or requiring CSF shunts)
- •7.11. Subjects with known or suspected immune deficiency (e.g. known IgA deficiency, immotile cilia syndrome, or Kartagener’s syndrome)
- •7.12. History of frequent nose bleeds
- •7.13. Bleeding disorders
- •8. Current medical issues
- •8.1. Acute upper respiratory tract infection in the four weeks preceding recruitment (as per definition in Annex 1)
- •8.2. Any uncontrolled medical or surgical condition (e.g. mental health conditions, epilepsy, narcolepsy or chronic pain) at the discretion of the study doctor
- •9. Any major pneumococcal illness or pneumonia requiring hospitalisation in the last 10 years
- •10. Medication
- •10.1 Any medication that may affect the immune system in the last 3 months (e.g. systemic steroids [IM/IV], Roaccutane, disease modifying anti-rheumatoid drugs)
- •10.2 Long-term antibiotic use
- •10.3 Recipient of monoclonal antibodies for any indication
- •10.4 Recipient of blood transfusion products within the last year
- •10.5 Any medication that may affect the coagulation system in the last 3 months (excluding aspirin)
- •10.6 Use of any medication or other product (prescription or over-the-counter) for symptoms of rhinitis or nasal congestion within the last 1 month
- •11. Maternal
- •11.1. Female participants who are pregnant
- •11.2. Female
研究者
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