Official Title: “Investigation of the Influence of Intranasal Mupirocin on the Prevalence of S. Aureus Nosocomial Infections by Eradication of Intranasal S. Aureus”

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.

Study Type: Interventional

Study Design: Prevention, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: Mupirocin

Primary Measures

• Staphylococcus aureus infection any time after 5 days of mupirocin ointment

Secondary Measures

• Presence or abscence of risk factors associated with S. aureus infections at any time during the hospital stay

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University Hospital Muenster

Overall Clinical Trial Officials and Contacts

Christof von Eiff, MD Principal Investigator University Hospital of Muenster, Institute of Medical Microbiology  

Information obtained from ClinicalTrials.gov on October 15, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00156377

Study ID Number: 4710F-186

ClinicalTrials.gov Identifier: NCT00156377

Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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