MRSA asymptomatic colonisation Infections and Infestations Streptococcus and staphylococcus
Conditions
Interventions
Patients who consent to take part in the trial will be randomised to topical treatment with either Prontoderm® or placebo for 10 days. Two preparations of the investigational products will be used, a
Sponsors
Geneva University Hospitals (Hôpitaux Universitaires de Genève) (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged greater than or equal to 18 years, either sex 2. Microbiologically documented MRSA carriage at any site, without any signs and symptoms of active MRSA infection 3. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Active MRSA infection 2. Chronic ulcers and deep-seated wounds colonized by MRSA 3. Presence of tracheostomy 4. Presence of external fixator colonised with MRSA 5. Unavailability of adequate help if subject is unable to self-administer the investigational product 6. Concurrent treatment with antimicrobial agents with anti-MRSA activity at the time of enrollment 7. Participation in another prospective clinical trial 8. Previous enrollment in the proposed study 9. Inability to understand or to follow the study protocol 10. Planned cardiac or orthopaedic implant surgery 11. Known or suspected hypersensitivity or allergy to any of the study drugs 12. Known hypersensitivity to chlorhexidine 13. Pregnancy or breastfeeding 14. Current or planned treatment with other agents that are topically applied to the skin or the nares 15. Critically ill patients hospitalised in the intensive care unit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decolonisation of MRSA carriage, expressed as the proportion of participants with a complete set of microbiologically negative swabs (nose and groin/perineum) at day 28 after the end of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Suppression of MRSA colonisation, expressed as the proportion of participants with a complete set of microbiologically negative swabs at day 2 after the end of treatment, irrespective of any subsequent culture results 2. Development of resistance to polyhexanide during the study defined as a statistically significant increase in the minimum inhibitory concentration in MRSA isolated at any time after the end of treatment 3. Adverse effects reported by patients (Irritation of the skin (redness, dryness, itch) or the anterior nares (dryness, itch) indicated on a scale from 0 - 5 (0 = none, 1 = trace, 2 = mild, 3 = moderate, 4 = severe and 5 = very severe) | — |
Countries
Switzerland
Outcome results
None listed