The efficacy of Prontoderm® for topical decolonisation of methicillin-resistant Staphylococcus aureus (MRSA) carriers
| ISRCTN | ISRCTN02288276 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN02288276 |
| Secondary identifying numbers | 10-085 |
- Submission date
- 23/12/2010
- Registration date
- 04/03/2011
- Last edited
- 29/10/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Stephan Harbarth
Scientific
Scientific
Service prévention et contrôle de l'infection
Hôpitaux Universitaires de Genève
Rue Gabrielle-Perret-Gentil 4
Genève 14
1211
Switzerland
| stephan.harbarth@hcuge.ch |
Study information
| Study design | Double-blind randomised placebo-controlled single centre interventional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet. |
| Scientific title | A double-blind, randomised, single centre study to evaluate the efficacy of polyhexanide (Prontoderm®) versus placebo for topical decolonisation of methicillin-resistant Staphylococcus aureus (MRSA) carriers |
| Study objectives | There is no difference with regard to suppressing or eliminating methicillin-resistant Staphylococcus aureus (MRSA) carriage in patients treated at the Geneva University Hospitals between topical administration of Prontoderm® (containing polyhexanide) and placebo (identical with the marketed product, except for the absence of polyhexanide) for 10 days. |
| Ethics approval(s) | Local Ethics Committee (Comité départemental d'éthique de médecine interne et médecine communautaire, Hôpitaux Universitaires de Genève), 25/08/2010, ref: 10-085 |
| Health condition(s) or problem(s) studied | MRSA asymptomatic colonisation |
| Intervention | 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 solution and a gel. The solution should be applied once a day to the hair and scalp using 3 - 5 single-use wash cloths. A sufficient amount of gel (ca. 0.5 - 1 mL) should be applied to the anterior nares in a circular motion three times a day using cotton swabs. A sufficient amount of gel (ca. 0.5 - 1 mL) should also be applied once a day to the entry site of catheters, if present, using a fresh sterile cotton swab for each site (working outwards). Total duration of treatment = 10 days Total duration of follow-up = 28 days from the end of treatment |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Prontoderm® |
| Primary outcome measure | 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 | 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) |
| Overall study start date | 05/01/2011 |
| Completion date | 30/09/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 160 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 05/01/2011 |
| Date of final enrolment | 30/09/2012 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Hôpitaux Universitaires de Genève
Genève 14
1211
Switzerland
1211
Switzerland
Sponsor information
Geneva University Hospitals (Hôpitaux Universitaires de Genève) (Switzerland)
Hospital/treatment centre
Hospital/treatment centre
c/o Prof Stephan Harbarth
Service prévention et contrôle de l'infection
Rue Gabrielle-Perret-Gentil 4
Genève 14
1211
Switzerland
| stephan.harbarth@hcuge.ch | |
| Website | http://www.hug-ge.ch/ |
"ROR" |
https://ror.org/01m1pv723 |
Funders
Funder type
Industry
B. Braun Medical AG (Switzerland)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2016 | Yes | No |
