Investigating disruption of the local and systemic human immune response caused by recent Staphylococcus aureus skin infectio
- Conditions
- CellulitisSkin and Connective Tissue Diseases
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 40
All participants:
Participants are eligible to be included in the study only if all of the following criteria apply:
1. Adults aged =18 years at time of consent
2. Willing and able to provide written informed consent and to comply with the study requirements, according to the investigator’s opinion
3. Agree to provide their National Insurance/Passport number for the purposes of payment of reimbursement expenses
4. Have internet access to allow completion of the e-Diary
5. Be in good general health as determined by medical history, history-directed physical examination, screening investigations performed, and the clinical judgement of the study team
SSTI cohort:
In addition, for the recent SSTI cohort:
1. Have had a recent SSTI probably (i.e. no alternative microbiological diagnosis with a compatible clinical syndrome) or definitely (i.e. confirmed by microbiological laboratory testing) caused by S. aureus infection diagnosed within the 6 months preceding the screening visit appointment
2. Agree to allow study staff to access their NHS health records (including hospital notes and laboratory records) as required for study purposes
Participants are excluded from the study if any of the following criteria apply:
1. History or evidence of:
1.1. Chronic dermatological conditions, including eczema, psoriasis, folliculitis, vitiligo, tinea corporis, and atopic dermatitis
1.2. Abnormal or impaired immune function, including congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy, including oral/inhaled corticosteroids, chemo-/radiotherapy, or monoclonal antibody treatment
1.3. Peripheral vascular (arterial and/or venous) disease
1.4. Clinically significant bleeding disorder, including clotting factor deficiency, coagulopathy, platelet disorder, or current anaemia
1.5. Active cancer/malignancy
2. Active skin or soft tissue infection
3. A history of keloid scarring
4. Any condition that, in the opinion of the Investigator, might compromise participant safety or interfere with the evaluation of the study intervention or interpretation of participant safety or study results
5. Inability to comply with any of the study requirements (at the discretion of study staff)
6. Significant blood donation or recent blood (/blood product) donation to NHS Blood and Transplant Service (within 90 days)
7. Tattoos or scarring to the forearm where OCT imaging/NPSB/microneedle assessment procedures will be performed
8. Volunteer incapable of giving fully informed consent
Temporary Exclusion:
Participants will be temporarily excluded from study procedures at V1 and V2 if presenting with the following:
1. Significant acute or acute-on-chronic infection within the previous 7 days or have experienced fever (>37.5°C) or subjective febrile symptoms within the previous 3 days (even with a negative COVID-19 test)
2. History of any antibiotic therapy during the previous 5 days
3. Any systemic corticosteroid (or equivalent) treatment in the previous 14 days, or for more than seven consecutive days within the past 3 months
4. Anaemia felt to be clinically significant by the study team
5. Receipt of any vaccine including SARS-CoV2 vaccines in the 28 days before or during the study period (D1-D28)
6. Participants meeting any of the temporary exclusion criteria on the day of the challenge will be deferred to a later date for a rescreening appointment, as agreed by the study team and Principal Investigator
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Combined abundance of immune cell populations in NPSB fluid collected at 2 visits 3 weeks apart (V1/V4), measured by single-cell RNA sequencing (scRNA-seq) within 6 months of an SSTI episode
- Secondary Outcome Measures
Name Time Method