Prophylaxis With Intranasal Mupirocin for Prevention of S. Aureus Infections

NCT ID: NCT00156377

Last Updated: 2010-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-11-30

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.

Conditions

Cross Infection; Staphylococcal Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

Mupirocin

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

University Hospital Muenster

OTHER

Sponsor Role: lead

Principal Investigators

Christof von Eiff, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Muenster, Institute of Medical Microbiology

Locations

Institute of Medical Microbiology, University Hospital of Muenster

Münster, , Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 11136954 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12374887 (View on PubMed)

Related Links

http://mibi1.uni-muenster.de/

Home page of the Institute of Medical Microbiology of the University Hospital of Muenster

Other Identifiers

4710F-186

Identifier Type: -

Identifier Source: org_study_id