Prophylaxis With Intranasal Mupirocin for Prevention of S. Aureus Infections

Staphylococcal Infections Clinical Trial

Official title:

Investigation of the Influence of Intranasal Mupirocin on the Prevalence of S. Aureus Nosocomial Infections by Eradication of Intranasal S. Aureus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00156377
• Other study ID #: 4710F-186
• Status: Completed
• Phase: Phase 4
• First received: September 8, 2005
• Last updated: May 24, 2010
• Start date: November 2002

Study information

• Verified date: September 2005
• Source: University Hospital Muenster
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Cross Infection
• Infection
• Staphylococcal Infections

Intervention

Drug:
• Mupirocin

Locations

Country	Name	City	State
Germany	Institute of Medical Microbiology, University Hospital of Muenster	Muenster

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Muenster	GlaxoSmithKline

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Staphylococcus aureus infection any time after 5 days of mupirocin ointment
Secondary	Presence or abscence of risk factors associated with S. aureus infections at any time during the hospital stay

External Links

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