ISRCTN38860497招募中不适用
Investigating the early responses to Staphylococcus aureus infection of the skin using a human infection model. The STARS study.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 干预模型
- Single Group
- 主要目的
- Human challenge study
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •An informed consent form has been signed and dated by the participant and the Investigator
- •Adults aged between 18 and 55 years inclusive at time of consent
- •In good health as determined by:
- •Medical history
- •History-directed physical examination
- •Screening investigations performed (routine laboratory tests, ECG, echocardiography)
- •The clinical judgement of the study team
- •Willing to be available in Sheffield for all required appointments
- •Able and willing (in the study team’s opinion) to comply with all study arrangements, including:
- •Availability for all required appointment windows
- •Able to use decolonisation treatment as directed
- •Willing to adhere to infection control precautions
- •Willing to allow study staff permission to contact their primary care provider to access medical history and to solicit opinion as to appropriateness for inclusion, where needed
- •Willing to allow study staff access to NHS health records as required for study purposes
- •Agree to have 24-hour contact with study staff during the 2-week period after challenge and be able to be contactable by mobile phone for the duration of study and until antimicrobial treatment completion
- •Have internet access to allow completion of the eDiary and real-time safety monitoring
- •Agree to avoid using medicated treatments (including shampoo and shower gel) until advised by a study doctor or until 14 days after challenge
- •Agree to provide their National Insurance/Passport number for the purposes of TOPS registration and for payment of reimbursement expenses
排除标准
- •History or evidence of organ dysfunction which could interfere with trial conduct or completion, including but not restricted to:
- •Cardiovascular disease, including diagnoses of valvular heart disease, hypertension, or previous episode(s) of infective endocarditis
- •Respiratory disease
- •Haematological disorders including anaemia felt to be clinically significant by the study team
- •Endocrine disease, including known or suspected diabetes mellitus
- •Renal or bladder disease
- •Autoimmune and metabolic disease
- •Psychiatric illness requiring in-patient stay or assessment
- •Known or suspected drug or alcohol dependence
- •Infectious disease, including personal or family history of severe infections including S. aureus
- •acute or chronic dermatologic conditions, including eczema, psoriasis, folliculitis, vitiligo atopic dermatitis and/or keloid scar formation
- •Any genetic, inherited or acquired predisposition that may alter the immune response to S. aureus infection, including a personal or family (first-degree relative) history including severe or invasive staphylococcal infection, Hyper-IgE (Job’s) syndrome (HIES), Chediak-Higashi syndrome, or Wiskott-Aldrich syndrome, IRAK-4 or MYD-88 deficiency, chronic granulomatous disease, HIV infection
- •Presence of implants (except for dental implants) or prosthetic material
- •Family history in 1st degree relative =50 years of age of aneurysmal disease, valvular heart disease, or sudden cardiac or unexplained death
- •Weight less than 50kg and/or a Body Mass Index (BMI) =18kg/m2 and =30kg/m2
- •Venous access deemed inadequate for the phlebotomy demands of the study
- •Scars or tattoos over or near the site of challenge
- •Detection of abnormal results from screening investigations including blood biochemistry, haematology, immunology and urinalysis i.e. grade 1 abnormality or above APPENDIX 6: Grading severity of laboratory results unless deemed not clinically significant and approved by the Principal Investigator.
- •12-lead electrocardiogram recording with clinically relevant abnormalities, including a prolonged correct QT interval (QTc >450 milliseconds) as judged by a study physician/Principle Investigator
- •Echocardiography demonstrating evidence of structural cardiac abnormalities, in particular relating to valve dysfunction, including hypertrophic cardiomyopathy, rheumatic heart disease, mitral valve prolapse (with regurgitation) and/or mitral annulus calcification, aortic valve disease (regurgitation, stenosis and/or sclerosis), congenital cardiac disease, including aortic stenosis, bicuspid aortic valve, pulmonary stenosis, ventricular septal defect, and patent ductus arteriosus
- •Taking medication, including analgesia, anti-inflammatories or antibiotics that may affect the study integrity, symptom reporting or interpretation of the study results
- •Receipt of blood or blood products, or loss (including blood donations) of =550mL or more of blood during the 3 months prior to the planned date of challenge or planned during the 3 months following the final visit
- •Contraindication to use of:
- •Study decolonisation treatment, mupirocin (or naseptin) nasal ointment, chlorhexidine (or octenisan) washes
- •Study antimicrobial/antibiotic treatment, hydrogen peroxide or fusidic acid cream, flucloxacillin or clarithromycin (for those who report penicillin allergy)
- •Scheduled elective surgery or other programmed procedures requiring general an
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