No registrations found.
ID
Source
Brief title
Health condition
Nosocomial Staphylococcus aureus infection.
Sponsors and support
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
Intervention
Outcome measures
Primary outcome
Nosocomial S. aureus infection until 6 weeks after discharge according to CDC-criteria.
Secondary outcome
1. Duration of hospital stay;
2. In-hospital mortality;
3. Time to nosocomial S. aureus infection.
Background summary
To 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.
Study objective
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 chloorhexidin containing soap within 24 hours after admission.
Study design
N/A
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 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.
Dr. Molewaterplein 40
Lonneke Bode
Dr. Molewaterplein 40
Rotterdam 3015 GD
The Netherlands
+31 (0)10 4633510 / +31 (0)10 4633511
L.Bode@erasmusmc.nl
Dr. Molewaterplein 40
Lonneke Bode
Dr. Molewaterplein 40
Rotterdam 3015 GD
The Netherlands
+31 (0)10 4633510 / +31 (0)10 4633511
L.Bode@erasmusmc.nl
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL310 |
| NTR-old | NTR348 |
| Other | : N/A |
| ISRCTN | ISRCTN56186788 |
Summary results
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.