MRSA
Conditions
Interventions
Trade Name: Bactroban
Pharmaceutical Form: Ointment
Trade Name: Hibiscrub
Pharmaceutical Form: Shampoo
Trade Name: CX Powder
Pharmaceutical Form: Cutaneous powder
Sponsors
St George's University of London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Subjects who are carriers of MRSA and who have been offered nasal decolonisation as part of their proposed normal medical care • Following verbal & written information about the trial, the subject has signed & dated informed consent before any study related activity was carried out. • Subject legally competent and able to communicate effectively with the study personnel Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: • Any reason that will prevent the subject from participating in the nasal decolonisation programme as determined by their consultant or past medical history. • Current participation or within less than 30 days in any other interventional clinical trial. • Subjects known or suspected of not being able to comply with trial protocol (e.g. alcoholism, drug dependency, or psychological state). • Pregnant or lactating females • Contraindicated in SmPC Subjects requiring use of an antimicrobial concomitant treatment during the study (apart from that prescribed as part of the MRSA skin decolonisation programme)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determine the level of decolonisation of nasal MRSA at 1 month after treatment with Bactroban Nasal® ointment, Chlorhexidine (4%) body and hair wash;Secondary Objective: To determine the rate of relapse To determine the concentration level of pseudomonic acid in the urine with actual adherence To correlate adherence to Mupirocin to MRSA decolinization To conduct a survey regarding subjects adherence ;Primary end point(s): • The primary endpoint will be the eradication of nasal Staphylococcus aureus at 30 days after 5 days of treatment, measured as the percentage (%) of participants who are culture negative in the anterior nares (number of participants/total number x 100) • The time to relapse measured by culture analysis of swabs for positivity at 30,60,90,120 and 180 +/-5 days • To conduct a survey regarding subjects adherence • To determine the concentration level of pseudomonic acid in the urine to determine actual adherence. • To correlate adherence to Mupirocin to MRSA decolonization. | — |
Countries
United Kingdom
Outcome results
None listed