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STEP study.

Prevention 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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28142
Enrollment
1800
Registered
2005-09-21
Start date
2005-10-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nosocomial Staphylococcus aureus infection.

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. Patient

Sponsors

Primary sponsor: Department of Medical Microbiology and Infectious Disease at Erasmus MC, University Medical Center, Rotterdam, the Netherlands. Secondary sponsors: Canisius Wilhelmina hospital, Nijmegen, the Netherlands Amphia hospital, Breda, the Netherlands University Medical Center Utrecht, Utrecht, the Netherlands VU Medical Center, Amsterdam, the Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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 criteria

Exclusion criteria: 1. 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.

Design outcomes

Primary

MeasureTime frame
Nosocomial S. aureus infection until 6 weeks after discharge according to CDC-criteria.

Secondary

MeasureTime frame
1. Duration of hospital stay; 2. In-hospital mortality; 3. Time to nosocomial S. aureus infection.

Contacts

Public ContactLonneke Bode

Erasmus Medical Center, Department of Medical Microbiology and Infectious Diseases, Dr. Molewaterplein 40

L.Bode@erasmusmc.nl+31 (0)10 4633510 / +31 (0)10 4633511

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)