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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00156377
Other study ID # 4710F-186
Secondary ID
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
Est. completion date
Est. primary completion date
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


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
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