Condition category
Infections and Infestations
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
08/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.erasmusmc.nl/

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

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20054045

Publication citations

  1. 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.

Additional files

Editorial Notes