Background The bacterium Staphylococcus aureus (S. aureus) is a leading cause of hospital-acquired infections. These infections are difficult to treat when there is increasing resistance to penicillin, known as methicillin resistant Staphylococcus aureus (MRSA). Patients who carry S. aureus in the nose and skin are prone to developing infections and many patients admitted to hospital are routinely “decolonised" to reduce this risk. The current standard treatment for nasal decolonisation is the antibiotic nasal mupirocin. There are concerns about over-reliance on a single treatment and the risk of mupirocin resistant MRSA. Robust evidence for alternatives to mupirocin is required Objective To investigate whether there are clinically and cost-effective alternatives to mupirocin for early nasal decolonisation of MRSA amongst adult hospital in-patients. Design and methods We designed a multicentre, three-arm parallel group, non-inferiority, randomised controlled trial with economic and qualitative evaluations, to recruit 3000 participants. Setting and participants Adult hospital in-patients identified as being colonised with MRSA on routine hospital admission screening were eligible for inclusion. Interventions Participants were randomised (ratio 1:1:1) to receive one of the following decolonisation treatments: Mupirocin (2%) nasal ointment (3g), Polyhexanide (0.1%) nasal gel (30ml) or Chlorhexidine (0.1%) with neomycin (0.5%) nasal cream (15g). Neither participants nor the investigators were blind to treatment allocation. Main outcome measures The primary outcome was successful early nasal decolonisation, defined as a negative trial specific nasal MRSA swab taken 48 hours following treatment completion. Secondary outcomes included successful early nasal decolonisation of MRSA not fully susceptible to mupirocin, successful late nasal decolonisation, acceptability of treatment to patients, MRSA infections, length of hospital in-patient stays and readmissions, adverse events and mortality. Outcomes were collected up to 4 weeks following treatment completion. Results Recruitment and retention of participants was much lower than expected. In total, 297 patients were assessed for eligibility and 32 patients randomised. All participants received treatment as allocated. Seven participants withdrew from the study. The mean age was 73.8 years (SD 16.6 years), with 62.5% (n=20) of participants being male. Semi-structured interviews were undertaken with patients (N=5), clinical teams (N=19) and clinical trials unit staff (N=5) to explore barriers and facilitators to recruitment and consent processes. Data from the qualitative evaluation contributed to progress discussions at trial management meetings and resulting remedial activities undertaken. Limitations The trial closed early after reaching < 2% of the recruitment target. The planned statistical and health economic analyses could not be conducted due to the limited data. The study objectives were not addressed due to poor recruitment. Conclusions It was not feasible to recruit to this trial in the current context, due to a reduced level of MRSA testing being undertaken in hospitals within the NHS. Future work To facilitate future research, further understanding of the routine decolonisation pathways in line with the revision to national guidance issued in 2021 is required. Validation of MRSA viability to increase processing time for nasal swabs could be undertaken and further exploration of the use of self-swabbing at home. Study registration The trial was prospectively registered as ISRCTN12184897 Funding details This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (reference number NIHR132718) and will be published in XXX Journal; Vol. XX, No XX. See the NIHR Journals Library website for further project information.
CORE (COnnecting REpositories)
CORE (COnnecting REpositories)