Methicillin-resistant Staphylococcus aureus (MRSA) positive colonisation Infections and Infestations
Conditions
Interventions
This is a multi-centre, pragmatic, randomised controlled non-inferiority trial, with an internal pilot phase to check the assumptions about recruitment and provide guidance on optimising the trial pro
Sponsors
South Tees Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult in-patient (aged 16 years old or over) 2. Eligible for MRSA screening on admission, based on the local hospital infection control policy, who are found to be colonised with MRSA
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to study treatment(s) or excipients 2. Allergy to peanut and/or soya 3. Day-case admissions 4. Patients identified to be colonised with MRSA in the outpatient setting 5. Previous participation in the TIDE trial or current participation in another trial of a medicinal product that does not allow co-enrolment 6. Patients actively undergoing another decolonisation treatment at the time of recruitment 7. Medical history that might, in the opinion of the attending clinician, put the patient at significant risk if they were to participate in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Successful early nasal decolonisation, defined as a negative trial-specific nasal MRSA swab taken 48 hours following treatment completion | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Successful early nasal decolonisation of MRSA not fully susceptible to mupirocin; sensitivities will be determined from a routine swab taken at baseline 2. Successful early nasal decolonisation of MRSA not fully susceptible to gentamicin (used as a marker of neomycin); sensitivities will be determined from a routine swab taken at baseline 3. Successful late nasal decolonisation, defined as a negative trial-specific nasal MRSA swab taken 4 weeks following treatment completion 4. Acceptability of treatment to patients measured using a Likert scale at 48 hours following the completion of treatment 5. MRSA infections: any confirmed MRSA infections (e.g., skin and wound infections, joint infections, endocarditis, pneumonia and bacteraemia), obtained from patient medical records or patient self-report up to 4 weeks following completion of treatment 6. Total length of hospital in-patient stays, obtained from patient medical records, up to 4 weeks following completion of treatment 7. Total length of hospital in-patient stays for patients diagnosed with an MRSA infection, obtained from patients’ medical records, up to 4 weeks following completion of treatment 8. Hospital readmissions, obtained from patients’ medical records, up to 4 weeks following completion of treatment 9. Adverse events obtained from patients' medical records or patient self-report up to 4 weeks following completion of treatment 10. Mortality obtained from patients' medical records up to 4 weeks following completion of treatment | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactLiz Cook
Outcome results
None listed