A feasibility study to assess the acceptability of Staphylococcus aureus decolonisation to prevent skin and soft tissue infections
| ISRCTN | ISRCTN26805113 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26805113 |
| Secondary identifying numbers | 24IC8767 |
- Submission date
- 23/04/2024
- Registration date
- 31/01/2025
- Last edited
- 31/01/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Infections and Infestations
Plain English Summary
Background and study aims
Skin and soft tissue infections (SSTIs), particularly those associated with the bacteria Staphylococcus aureus (S.aureus), are common in certain UK populations such as military, prison personnel, returning travellers, children and sport teams. Of concern is the ability of certain strains like Panton-Valentine Leukocidin S.aureus (PVL-SA) and methicillin-resistant S.aureus (MRSA) to cause outbreaks of boils and abscesses, impacting on the health of the individual and their household. Furthermore, SSTIs lead to hospital admissions and recurrent antibiotic use. Nasal carriage of S.aureus can increase a risk of infections following certain procedures: dialysis, cardiothoracic and orthopaedic surgery and so now it is routine to decolonise these patients using a body treatment (nasal ointment and skin wash). This feasibility study will assess the acceptability of routine decolonisation on S. aureus carriage and SSTIs using a high-risk military population at the Infantry Training Centre (ITC), Catterick.
Who can participate?
Military recruits aged 16 - 35.5 years
What does the study involve?
Military recruits at ITC will be consented and then randomised to receive weekly decolonization therapy (mupirocin nasal ointment and Hibiscrub body wash/shampoo) or mupirocin and octenisan with 25 consented participants in each group. The feasibility study will assess the acceptability of decolonisation to the study participant and healthcare worker involved using an electronic database called OpenClinica. The study will assess the ability to collect study outcomes (SSTI rates, antimicrobial resistance of colonising bacteria, referral to secondary care, serious adverse events and use of point of care testing). The study will last for 12 weeks.
What are the possible benefits and risks of participating?
The participation of individuals will support the refinement of military clinical guidance and provide information for future research. There are potential minor adverse effects associated with certain elements of the study, such as discomfort from having a swab and this will be minimise by training and involving the participant in the sampling. There is the possibility of intolerance or reactions to the decolonisation regimens and anyone with a known reaction will be excluded.
Where is the study run from?
Infantry Training Centre, Catterick (UK)
Imperial College London (UK)
When is the study starting and how long is it expected to run for?
April 2024 to June 2026
Who is funding the study?
Defence Medical Services Research Strategy Group (UK)
Who is the main contact?
lucylamb@nhs.net
Contact information
Scientific, Principal Investigator
Commonwealth Building, Imperial College London
Hammersmith, London
W12 0NN
United Kingdom
| Phone | +44 7769 712 402 |
|---|---|
| lucylamb@nhs.net |
Scientific
Imperial College Faculty of Medicine
Du Cane Road
London
W12 0NN
United Kingdom
| Phone | +44 2083833135 |
|---|---|
| s.sriskandan@imperial.ac.uk |
Public
Vimy Barracks
Catterick
DL9 3PS
United Kingdom
| donna.tupper257@mod.gov.uk |
Study information
| Study design | Interventional randomized controlled feasibility study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised feasibility trial |
| Study setting(s) | Other |
| Study type | Safety |
| Scientific title | A feasibility study to assess the acceptability of Staphylococcus aureus decolonisation to prevent skin and soft tissue infections |
| Study hypothesis | The main aim of the feasibility project will be to assess the acceptability of weekly Staphylococcus aureus decolonisation using hIbiscrub and bactroban or octenisan and bactroban to prevent against skin and soft tissue infections. The data from the feasibility study will inform future research and current guidance. In order to meet the main aim the feasibility study will assess: - the acceptability of decolonisation to the consented participant - the willingness of individuals to adhere to the decolonisation and collection of samples - the willingness of study participants and clinical teams to be involved - the assessment of processes including monitoring of any serious adverse events, hospital admission rates and change in antimicrobial resistance rates of S.aureus carriage rates. |
| Ethics approval(s) |
Approved 25/07/2024, Ministry of Defence Research Ethics Committee (DSTL Portondown West, Fareham, PO17 6AD, United Kingdom; +44 (0)300 153 5372; DST-MODRECTeam@mod.gov.uk), ref: 2297/MOD/24 |
| Condition | Acceptability of S.aureus decolonisation to prevent against skin and soft tissue infections in military recruits |
| Intervention | The feasibility study will assess the acceptability of S.aureus decolonisation to prevent skin and soft tissue infections. Prior to decolonisation individuals will be screen for S.aureus at 4 body sites. Individuals will be randomised to receive decolonisation therapy weekly either: chlorhexidine 4% body wash and shampoo with mupirocin 2% nasal ointment or octenisan body wash and shampoo with mupirocin 2% nasal ointment. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Prophylaxis, Therapy, Others (This is a feasibility study to assess the acceptability of decolonisation to prevent against skin and soft tissue infection to allow the refinement of a future study.) |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | Bactroban 2% ointment (2% w/w mupirocin free acid) [Mupirocin 2%], Chlorhexidine 4% (Hibiscrub) [Chlorhexidine Gluconate 40 mg/ml (4.0% w/v).] |
| Primary outcome measure | Incidence of skin and soft tissue infection at time frame 12 weeks recorded in each individual participants Defence Medical Information Capability programme (DMICP). |
| Secondary outcome measures | 1. Admission to Primary care facility or secondary care recorded in each individual participants DMICP record. Time frame 12 weeks. 2. Serious adverse events measured using questionnaires at 1, 4 and 12 weeks. 3. Antimicrobial resistance rates of Staphylococcus aureus acquired from 4 body sites (nose, throat, axilla and groin) using bacterial swabs at 3 time points 1, 4 and 12 weeks. |
| Overall study start date | 19/04/2024 |
| Overall study end date | 30/06/2026 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Upper age limit | 35.5 Years |
| Sex | Both |
| Target number of participants | 50 |
| Participant inclusion criteria | 1. Over the age of 16 years and below 35 years and 6 months 2. Military and deemed fit to attend phase 1 training |
| Participant exclusion criteria | A participant will be excluded from the study if deemed inappropriate by the IMO or ITC Medical Staff |
| Recruitment start date | 25/02/2025 |
| Recruitment end date | 30/06/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
-
United Kingdom
Sponsor information
University/education
Research Governance and Integrity, Imperial College London, Room 221, Medical School Building, St Marys Campus, Norfolk Place
London
W2 1PG
England
United Kingdom
| Phone | +44 20 7594 9480 |
|---|---|
| k.boland@imperial.ac.uk | |
| Website | http://www.imperial.ac.uk/ |
"ROR" |
https://ror.org/041kmwe10 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/10/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Peer reviewed scientific journals Internal report Conference presentation Publication on website Other publication Submission to regulatory authorities The feasibility study will be registered with ClinicalTrials.gov. The results will be shared with the Academic Department of Military medicine and collaborators with the study (UK HSA, Staphylococcal reference laboratory). All data will be anonymous. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to confidentiality. |
Editorial Notes
23/04/2024: Trial's existence confirmed by NHS HRA.
