Staphylococcus aureus nasal colonisation Infections and Infestations
Conditions
Interventions
This study is a two-stage, unblinded, strain-randomised Controlled Human Infection Model (CHIM). It is multicentre, starting in one location with sequential opening of UK locations as required. It is
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Adults between 18 to 55 years old (inclusive) at the time of enrolment (defined by the start of first decolonisation therapy) 2. Medically healthy, such that according to investigator judgement, hospitalisation within the study period is not anticipated, and the participant appears likely to be able to remain a study participant through to the end of protocol-specified follow-up. Planned elective procedures for pre-existing conditions may be allowable if S. aureus colonisation is not deemed to put the participant at increased risk of harm and if the elective procedure does not routinely involve, and is not likely to involve, decolonisation and/or antibiotic therapy 3. Fluent spoken English – to ensure a comprehensive understanding of the research project and their proposed involvement 4. Capacity to provide written informed consent in English for participation in the study 5. Able to attend the scheduled visits and to comply with all study procedures, including internet access for the recording of electronic diaries after issue of decolonisation therapy and S. aureus challenge 6. Able to follow and adhere to hygiene advice as well as the decolonisation protocol which includes daily shower and hair wash 7. Willing and able to avoid planned, non-essential non-study antibiotics for the duration of the study 8. Willing and able to avoid intranasal and inhaled products (including nasal steroids) unless prescribed by the study team for the duration of the study 9. Able to adhere to standard hygiene advice at home 10. Willing to allow confirmation of past medical history either through provision of, or access to, a medical record summary or other medical documentation or to allow investigators to obtain a copy of their medical history via their GP practice or via electronic patient records 11. Willing to allow their GP and/or consultant, if appropriate, to be notified of participation in the study 12. Willing to provide their national insurance number or passport number to be registered on The Trial Over-Volunteering Prevention System (TOPS) 13. For participants of childbearing potential only: Willing to use effective contraception for the duration of the study AND to have a pregnancy test on the day of screening, and challenge or as indicated by the study doctor
Exclusion criteria
Exclusion criteria: 1. Research participants 1.1. Participation in another research study in which procedures could compromise the integrity of this study (for example immune modulating or stimulating treatments) or the safety of the participant (for example significant volumes of blood taken), or planning to do so within the study period 2. Vaccination (self-reported with or without confirmation from GP questionnaire or medical records or summary if deemed necessary at clinician discretion) 2.1. Planned vaccination in the two months following final challenge 2.2. Live vaccination within the 4 weeks prior to first challenge 3. Allergy 3.1. Have an allergy or intolerance to beta-lactam antibiotics 3.2. Have an allergy or intolerance to more than one of doxycycline, co-trimoxazole, clindamycin and linezolid 3.3. Have an allergy or intolerance to any of the agents used for decolonisation 4. Specific health history (self-reported with or without confirmation from GP questionnaire or medical records or summary if deemed necessary at clinician discretion) 4.1. History of severe S. aureus infection, including PVL-associated disease 4.2. Atopic dermatitis 4.3. Psoriasis, eczema or other chronic skin condition requiring treatment in the last year 4.4. Compromised skin barrier function at the discretion of the investigator 4.5. Known structural heart issues at the discretion of the investigator, including but not limited to PFO, VSD and bicuspid AV 4.6. Implanted prosthetic material including but not limited to cochlear implants, orthopaedic implants, implantable cardiac devices, cardiac valves and neurological stimulators 4.7. Recurrent sinusitis 4.8. Previous sinus surgery 4.9. Planned surgical, dental, orthodontic, dental hygienist or pre-operative appointment over the study period 5. General health history (self-reported and or confirmed from GP questionnaire or medical records or summary if deemed necessary). Moderate to severe ill health including but not limited to: 5.1. Asplenia or dysfunction of the spleen 5.2. Chronic respiratory disease (for example asthma on medication, COPD, emphysema, bronchiectasis) 5.3. Chronic heart disease (for example angina, ischaemic heart disease, chronic heart failure). Controlled stable hypertension with or without angina may be included 5.4. Chronic kidney disease (for example nephrotic syndrome, kidney transplant, on dialysis) 5.5. Chronic liver disease (for example cirrhosis, biliary atresia, hepatitis) 5.6. Chronic neurological conditions 5.7. Connective tissue disease 5.8. Dementia 5.9. Diabetes mellitus (including diet controlled) 5.10. Immunosuppression or history of receiving immunosuppressive therapy at the discretion of the investigator 5.11. Individuals with cochlear implants 5.12. Individuals with major cerebrospinal fluid leaks (for example following trauma, major skull surgery or requiring CSF shunt) 5.13. History of a bleeding disorder (for example factor deficiency, coagulopathy or platelet disorder) or prior history of significant bleeding or bruising following IM injections or venepuncture 5.14. Any uncontrolled medical, surgical or mental health conditions at the discretion of the study doctor 5.15. Significant mental health condition (for example previous admissions in a psychiatric unit, at the discretion of the clinician)
Countries
England, United Kingdom
Contacts
Public ContactConor Whelan
Outcome results
None listed