Prophylaxis With Intranasal Mupirocin for Prevention of S. Aureus Infections
Information source: University Hospital Muenster
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cross Infection; Staphylococcal Infections
Intervention: Mupirocin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University Hospital Muenster Official(s) and/or principal investigator(s):
Christof von Eiff, MD, Principal Investigator, Affiliation: University Hospital of Muenster, Institute of Medical Microbiology
Summary
In order to evaluate the effect of eliminating nasal carriage by mupirocin prophylaxis on
subsequent Staphylococcus aureus infection, a prospective randomized trial was performed
particularly including patients with predisposing risk factors for S. aureus infections.
Clinical Details
Official title: Investigation of the Influence of Intranasal Mupirocin on the Prevalence of S. Aureus Nosocomial Infections by Eradication of Intranasal S. Aureus
Study design: Prevention, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Staphylococcus aureus infection any time after 5 days of mupirocin ointment
Secondary outcome: Presence or abscence of risk factors associated with S. aureus infections at any time during the hospital stay
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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
Locations and Contacts
Institute of Medical Microbiology, University Hospital of Muenster, Muenster 48149, Germany
Additional Information
Home page of the Institute of Medical Microbiology of the University Hospital of Muenster
Related publications: 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.
Starting date: November 2002
Last updated: September 13, 2005
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