Condition category
Infections and Infestations
Date applied
23/12/2010
Date assigned
04/03/2011
Last edited
29/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Stephan Harbarth

ORCID ID

Contact details

Service prévention et contrôle de l'infection
Hôpitaux Universitaires de Genève
Rue Gabrielle-Perret-Gentil 4
Genève 14
1211
Switzerland
-
stephan.harbarth@hcuge.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

10-085

Study information

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

Acronym

Study hypothesis

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

Local Ethics Committee (Comité départemental d'éthique de médecine interne et médecine communautaire, Hôpitaux Universitaires de Genève), 25/08/2010, ref: 10-085

Study design

Double-blind randomised placebo-controlled single centre interventional study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet.

Condition

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

Phase

Phase IV

Drug names

Prontoderm®

Primary outcome measures

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 trial start date

05/01/2011

Overall trial end date

30/09/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

160

Participant 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

Recruitment start date

05/01/2011

Recruitment end date

30/09/2012

Locations

Countries of recruitment

Switzerland

Trial participating centre

Hôpitaux Universitaires de Genève
Genève 14
1211
Switzerland

Sponsor information

Organisation

Geneva University Hospitals (Hôpitaux Universitaires de Genève) (Switzerland)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

http://www.hug-ge.ch/

Funders

Funder type

Industry

Funder name

B. Braun Medical AG (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26507428

Publication citations

Additional files

Editorial Notes