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Prophylaxis With Intranasal Mupirocin for Prevention of S. Aureus Infections

Primary Purpose

Cross Infection, Staphylococcal Infections

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Mupirocin
Sponsored by
University Hospital Muenster
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cross Infection focused on measuring Mupirocin, Staphylococcus aureus, Nasal Cavity, Preventive measures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Medical Microbiology, University Hospital of Muenster

Outcomes

Primary Outcome Measures

Staphylococcus aureus infection any time after 5 days of mupirocin ointment

Secondary Outcome Measures

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

Full Information

First Posted
September 8, 2005
Last Updated
May 24, 2010
Sponsor
University Hospital Muenster
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00156377
Brief Title
Prophylaxis With Intranasal Mupirocin for Prevention of S. Aureus Infections
Official Title
Investigation of the Influence of Intranasal Mupirocin on the Prevalence of S. Aureus Nosocomial Infections by Eradication of Intranasal S. Aureus
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital Muenster
Collaborators
GlaxoSmithKline

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cross Infection, Staphylococcal Infections
Keywords
Mupirocin, Staphylococcus aureus, Nasal Cavity, Preventive measures

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1200 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Mupirocin
Primary Outcome Measure Information:
Title
Staphylococcus aureus infection any time after 5 days of mupirocin ointment
Secondary Outcome Measure Information:
Title
Presence or abscence of risk factors associated with S. aureus infections at any time during the hospital stay

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christof von Eiff, MD
Organizational Affiliation
University Hospital of Muenster, Institute of Medical Microbiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Medical Microbiology, University Hospital of Muenster
City
Muenster
ZIP/Postal Code
48149
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
11136954
Citation
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.
Results Reference
background
PubMed Identifier
12374887
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. doi: 10.1056/NEJM200210103471518. No abstract available.
Results Reference
background
Links:
URL
http://mibi1.uni-muenster.de/
Description
Home page of the Institute of Medical Microbiology of the University Hospital of Muenster

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Prophylaxis With Intranasal Mupirocin for Prevention of S. Aureus Infections

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