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