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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 10.1186/ISRCTN56186788
ClinicalTrials.gov identifier
EudraCT number
Public title 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
Scientific title
Acronym STEP study
Serial number at source NTR348
Study hypothesis 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.
Lay summary
Ethics approval Ethics approval received from the local medical ethics committee
Study design Randomised double blind placebo controlled parallel group trial
Countries of recruitment Netherlands
Disease/condition/study domain Nosocomial Staphylococcus aureus infection
Participants - 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
Participants - 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
Anticipated start date 01/10/2005
Anticipated end date 01/04/2007
Status of trial Completed
Patient information material
Target number of participants 1800
Interventions 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.
Primary outcome measure(s) Nosocomial S. aureus infection until 6 weeks after discharge according to Centers for Disease Control and prevention (CDC)-criteria.
Secondary outcome measure(s) 1. Duration of hospital stay
2. In-hospital mortality
3. Time to nosocomial S. aureus infection
Sources of funding The Netherlands Organization for Health Research and Development (ZonMw) (Netherlands)
Trial website
Publications 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20054045
Contact name Dr  Lonneke  Bode
  Address Erasmus Medical Center
Department of Medical Microbiology and Infectious Diseases
Dr. Molewaterplein 40
  City/town Rotterdam
  Zip/Postcode 3015 GD
  Country Netherlands
  Tel +31 (0)10 4633510/4633511
  Fax +31 (0)10 4633875
  Email L.Bode@erasmusmc.nl
Sponsor Erasmus Medical Centre (Netherlands)
  Address Dr Molewaterplein 40/50
  City/town Rotterdam
  Zip/Postcode 3000 CA
  Country Netherlands
  Sponsor website: http://www.erasmusmc.nl/
Date applied 20/12/2005
Last edited 08/01/2010
Date ISRCTN assigned 20/12/2005
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