Clinical trial NCT00156377: Prophylaxis With Intranasal Mupirocin for Prevention of S. Aureus Infections
Official title: Investigation of the Influence of Intranasal Mupirocin on the Prevalence of S. Aureus Nosocomial Infections by Eradication of Intranasal S. Aureus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cross Infection
Staphylococcal Infections
Keywords: Mupirocin
Staphylococcus aureus
Nasal Cavity
Preventive measures
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2005-09-12
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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 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

Primary outcomes:
measure: Staphylococcus aureus infection any time after 5 days of mupirocin ointment
Secondary outcomes:
measure: Presence or abscence of risk factors associated with S. aureus infections at any time during the hospital stay
Other outcomes:
Locations:
city: Muenster
country: Germany
facility: Institute of Medical Microbiology, University Hospital of Muenster
Study officials:
affiliation: University Hospital of Muenster, Institute of Medical Microbiology
name: Christof von Eiff, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1056/NEJM200101043440102.
citation: 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. doi: 10.1056/NEJM200210103471518. No abstract available.