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
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 |
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Germany | Institute of Medical Microbiology, University Hospital of Muenster | Muenster |
Lead Sponsor | Collaborator |
---|---|
University Hospital Muenster | GlaxoSmithKline |
Germany,
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
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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