Contact information
Type
Scientific
Primary contact
Dr Lonneke Bode
ORCID ID
Contact details
Erasmus Medical Center
Department of Medical Microbiology and Infectious Diseases
Dr. Molewaterplein 40
Rotterdam
3015 GD
Netherlands
+31 (0)10 4633510/4633511
L.Bode@erasmusmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR348
Study information
Scientific title
Acronym
STEP study
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.
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Randomised double blind placebo controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
01/10/2005
Overall trial end date
01/04/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1800
Participant 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
Recruitment start date
01/10/2005
Recruitment end date
01/04/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
Erasmus Medical Center
Rotterdam
3015 GD
Netherlands
Sponsor information
Organisation
Erasmus Medical Centre (Netherlands)
Sponsor details
Dr Molewaterplein 40/50
Rotterdam
3000 CA
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
The Netherlands Organization for Health Research and Development (ZonMw) (Netherlands)
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
Basic results (scientific)
Publication list
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20054045
Publication citations
-
Results
Bode LG, Kluytmans JA, Wertheim HF, Bogaers D, Vandenbroucke-Grauls CM, Roosendaal R, Troelstra A, Box AT, Voss A, van der Tweel I, van Belkum A, Verbrugh HA, Vos MC, Preventing surgical-site infections in nasal carriers of Staphylococcus aureus., N. Engl. J. Med., 2010, 362, 1, 9-17, doi: 10.1056/NEJMoa0808939.