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STEP study.


- candidate number1718
- NTR NumberNTR348
- ISRCTNISRCTN56186788
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR21-sep-2005
- Secondary IDsN/A 
- Public TitleSTEP study.
- Scientific TitlePrevention of nosocomial Staphylococcus aureus infections after rapid detection and eradication of S. aureus carriage in patients at risk; a randomized placebo controlled multi-center trial.
- ACRONYMSTEP study
- hypothesisNosocomial Staphylococcus aureus infections in S. aureus nasal carriers can be reduced by 50%, by application of mupirocin nasal ointment in combination with washing with chloorhexidin containing soap within 24 hours after admission.
- Healt Condition(s) or Problem(s) studiedNosocomial Staphylococcus aureus infection
- Inclusion criteria1. Adult patients (>= 18 years);
2. Rapid detection positive for S. aureus nasal carriage;
3. Expected admission of >= 4 days;
4. Treatment can be started <= 24 hours after admission;
5. Informed consent.
- Exclusion criteria1. S. aureus infection at enrollment;
2. Allergy to mupirocin;
3. Allergy to chlorhexidin;
4. Pregnancy or lactation;
5. Recent (< 4 weeks) mupirocin use;
6. Nasal corpus alienum.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2005
- planned closingdate1-apr-2007
- Target number of participants1800
- InterventionsThe 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 nares 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 outcomeNosocomial S. aureus infection until 6 weeks after discharge according to CDC-criteria.
- Secondary outcome1. Duration of hospital stay;
2. In-hospital mortality;
3. Time to nosocomial S. aureus infection.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMD. Lonneke Bode
- CONTACT for SCIENTIFIC QUERIESMD. Lonneke Bode
- Sponsor/Initiator Erasmus Medical Center, Department of Medical Microbiology and Infectious Disease, Canisius Wilhelmina hospital, Amphia Hospital Breda, University Medical Center Utrecht (UMCU), VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsCDC definitions for nosocomial infections. J.S. Garner et al. In: Olmsted RN, ed.: APIC Infection control and applied epidemiology: Principles and practice. St. Louis: Mosby; 1996:pp A-1--A-20. Mupirocin prophylaxis against nosocomial Staphylococcus aureus infections in nonsurgical patients. A randomized study. H.F.L. Wertheim et al. Ann Intern Med 2004;140:419-25.
- Brief summaryTo assess whether the treatment of S. aureus carriage with mupirocin nasal ointment in combination with skin disinfection (chlorhexidin) significantly reduces nosocomial S. aureus infections in S. aureus carriers, we will conduct a double-blinded placebo controlled multi-center trial. For 18 months patients will be screened for S. aureus nasal carriage at admission through nasal swabs by a rapid molecular technique. Carriers are randomly assigned to receive either mupirocin nasal ointment in combination with disinfecting soap (chlorhexidin) or placebo ointment in combination with placebo disinfecting soap for five consecutive days, starting within 24 hours after admission to the hospital.
- Main changes (audit trail)
- RECORD21-sep-2005 - 27-nov-2009


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