Prevention of nosocomial Staphylococcus aureus infections after rapid detection and eradication of S. aureus carriage in patients at risk: a randomised placebo controlled multi-center trial
| ISRCTN | ISRCTN56186788 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56186788 |
| Secondary identifying numbers | NTR348 |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 08/01/2010
- 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
Dr Lonneke Bode
Scientific
Scientific
Erasmus Medical Center
Department of Medical Microbiology and Infectious Diseases
Dr. Molewaterplein 40
Rotterdam
3015 GD
Netherlands
| Phone | +31 (0)10 4633510/4633511 |
|---|---|
| L.Bode@erasmusmc.nl |
Study information
| Study design | Randomised double blind placebo controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | STEP study |
| Study objectives | Nosocomial Staphylococcus aureus infections in S. aureus nasal carriers can be reduced by 50%, by application of mupirocin nasal ointment in combination with washing with chlorhexidine containing soap within 24 hours after admission. |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Nosocomial Staphylococcus aureus infection |
| Intervention | The comparison intervention consists of mupirocin 2% nasal ointment and chlorhexidindigluconate 4% body soap. The control intervention consists of placebo nasal ointment and placebo body soap. Patients are treated for 5 days: twice daily application of nasal ointment (with the size of a match's head) in both nostrils and once daily washing of the entire body with soap. Patients who are still admitted at 3 weeks and 6 weeks after admission will receive the same study medication again. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Mupirocin, chlorhexidindigluconate |
| Primary outcome measure | Nosocomial S. aureus infection until 6 weeks after discharge according to Centers for Disease Control and prevention (CDC)-criteria. |
| Secondary outcome measures | 1. Duration of hospital stay 2. In-hospital mortality 3. Time to nosocomial S. aureus infection |
| Overall study start date | 01/10/2005 |
| Completion date | 01/04/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 1800 |
| Key inclusion criteria | 1. Adult patients (greater than or equal to 18 years) 2. Rapid detection positive for S. aureus nasal carriage 3. Expected admission of greater than or equal to 4 days 4. Treatment can be started less than or equal to 24 hours after admission 5. Informed consent |
| Key exclusion criteria | 1. S. aureus infection at enrolment 2. Allergy to mupirocin 3. Allergy to chlorhexidin 4. Pregnancy or lactation 5. Recent (less than 4 weeks) mupirocin use 6. Nasal corpus alienum |
| Date of first enrolment | 01/10/2005 |
| Date of final enrolment | 01/04/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus Medical Center
Rotterdam
3015 GD
Netherlands
3015 GD
Netherlands
Sponsor information
Erasmus Medical Centre (Netherlands)
University/education
University/education
Dr Molewaterplein 40/50
Rotterdam
3000 CA
Netherlands
| Website | http://www.erasmusmc.nl/ |
|---|---|
"ROR" |
https://ror.org/018906e22 |
Funders
Funder type
Research organisation
The Netherlands Organization for Health Research and Development (ZonMw) (Netherlands)
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 | 07/01/2010 | Yes | No |
