The efficacy of Prontoderm® for topical decolonisation of methicillin-resistant Staphylococcus aureus (MRSA) carriers
- Conditions
- MRSA asymptomatic colonisationInfections and InfestationsStreptococcus and staphylococcus
- Registration Number
- ISRCTN02288276
- Lead Sponsor
- Geneva University Hospitals (Hôpitaux Universitaires de Genève) (Switzerland)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 160
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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<br>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<br>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)