Prophylaxis with Intranasal Mupirocin for Prevention of S. Aureus Infections - Article
Clinical Trial: Prophylaxis with Intranasal Mupirocin for Prevention of S. Aureus Infections
This study has been completed.
|Cross Infection |
| Drug: Mupirocin ||Phase IV |
MedlinePlus related topics: Staphylococcal Infections
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Investigation of the Influence of Intranasal Mupirocin on the Prevalence of S. Aureus Nosocomial Infections by Eradication of Intranasal S. Aureus
Secondary Outcomes: Presence or abscence of risk factors associated with S. aureus infections at any time during the hospital stay
Expected Total Enrollment: 1200
Study start: November 2002
In a past study, we showed that there is a strong correlation between strains colonizing the anterior nares, strains isolated from the presumed foci of infection, and strains isolated from blood in patients with Staphylococcus aureus bacteremia. These results suggested that a substantial proportion of cases of systemic S. aureus infections appear to be of endogenous origin and that eradication of nasal colonization should be the chief strategy for reducing the incidence of hospital-acquired S. aureus infections.
In order to evaluate the effect of eliminating nasal carriage by mupirocin prophylaxis on subsequent S. aureus infection, a prospective randomized trial was performed particularly including patients with predisposing risk factors for S. aureus infections. All patients admitted to selected units in clinics for anaesthesiology, hemato-oncology, cardiac surgery, and orthopedics at the University Hospital of Muenster were regularly screened for nasal carriage, i.e. at admission and, subsequently, on a weekly basis. S. aureus carrying patients were prospectively randomized, to be either treated with mupirocin for 5 days, or left untreated. Patients infected with S. aureus at admission and patients detected to be MRSA carrier were excluded from randomization.
Patients were regularly seen during the course of their hospital stay and predisposing/conditional risk factors were systematically documented. In both groups (untreated patients and patients with mupirocin prophylaxis), all nosocomial infections were documented according to CDC guidelines. If infected, specimens were taken for microbiological diagnosis. All S. aureus isolates (from the anterior nares as well as from the focus of infection) were collected and were genotyped.
- All patients admitted to selected units in clinics for anaesthesiology, hemato-oncology, cardiac surgery, and orthopedics at the University Hospital of Muenster (following information on the study and agreement of the patient).
- Patients infected with S. aureus at admission
- S. aureus infection within 48 hours following admission
- Patients detected to be carrier of Methicillin-resistant S. aureus
- Hospital stay shorter than 72 hours
- Patients with anatomic abnormalities in the anterior nares
- Allergy or hypersensitivity to mupirocin or other substances of the nasal ointment
- Persons younger than 18 years
- Known pregnancy
- Persons with psychiatric diseases
- Persons with limited contractual capability and judiciousness
Institute of Medical Microbiology, University Hospital of Muenster, Muenster, 48149, Germany
Christof von Eiff, MD, Principal Investigator, University Hospital of Muenster, Institute of Medical Microbiology
von Eiff C, Becker K, Machka K, Stammer H, Peters G. Nasal carriage as a source of Staphylococcus aureus bacteremia. Study Group. N Engl J Med. 2001 Jan 4;344(1):11-6.
von Eiff C, Kipp F, Becker K. Intranasal mupirocin to prevent postoperative infections. N Engl J Med. 2002 Oct 10;347(15):1207-8; author reply 1207-8. No abstract available.
Last Updated: September 9, 2005
Record first received: September 8, 2005
ClinicalTrials.gov Identifier: NCT00156377
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2005-09-13
- Vancomycin-Intermediate/Resistant Staphylococcus aureus(VISA/VRSA) Infections (Centers for Disease Control and Prevention)