- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00156377
Prophylaxis With Intranasal Mupirocin for Prevention of S. Aureus Infections
Investigation of the Influence of Intranasal Mupirocin on the Prevalence of S. Aureus Nosocomial Infections by Eradication of Intranasal S. Aureus
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Muenster, Germany, 48149
- Institute of Medical Microbiology, University Hospital of Muenster
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Staphylococcus aureus infection any time after 5 days of mupirocin ointment
|
Secondary Outcome Measures
Outcome Measure |
---|
Presence or abscence of risk factors associated with S. aureus infections at any time during the hospital stay
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Christof von Eiff, MD, University Hospital of Muenster, Institute of Medical Microbiology
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Disease Attributes
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Iatrogenic Disease
- Infections
- Communicable Diseases
- Staphylococcal Infections
- Cross Infection
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Bacterial Agents
- Protein Synthesis Inhibitors
- Mupirocin
Other Study ID Numbers
- 4710F-186
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cross Infection
-
Erasmus Medical CenterAmbu A/S; Maag Lever Darm StichtingCompletedEsophagogastroduodenoscopy | Gastroscopy | Equipment Design | Equipment Contamination / Prevention & Control | Cross Infection / Prevention & Control | Disposable Equipment | Infection Control / MethodsNorway, Netherlands
-
Southeast University, ChinaUnknown
-
Federico II UniversityCompleted
-
Dartmouth-Hitchcock Medical CenterHarbor Medical Inc.CompletedNosocomial InfectionUnited States
-
Mahidol UniversityUnknown
-
Bnai Zion Medical CenterUnknown
-
Royal Brompton & Harefield NHS Foundation TrustCompleted
-
Second Affiliated Hospital, School of Medicine,...The Second Affiliated Hospital of Jiaxing University; Changxing People's Hospital and other collaboratorsRecruiting
-
University of AlbertaCompleted
-
Mahidol UniversityUnknown
Clinical Trials on Mupirocin
-
Kwong Wah HospitalThe Hong Kong Society of NephrologyUnknownRate of Exit Site Infection | Rate of Atypical Mycobacterial Infection | Rate of Peritoneal DialysisHong Kong
-
University of Nove de JulhoCompletedRenal Insufficiency, Chronic | PhotochemotherapyBrazil
-
Reig Jofre GroupCompleted
-
US Department of Veterans AffairsUniversity of Michigan; Saint Joseph Mercy Health SystemCompleted
-
Gundersen Lutheran Medical FoundationGundersen Lutheran Health SystemCompletedSurgical Site InfectionsUnited States
-
Jiangxi Provincial Cancer HospitalRecruitingQuality of Life | Nasopharyngeal Carcinoma | Bacterial Colonization | Radiation-induced Oral MucositisChina
-
University of ChicagoCompletedEndophthalmitis | Prophylaxis | Cataract SurgeryUnited States
-
Brooke Army Medical CenterGlaxoSmithKline; Becton, Dickinson and CompanyCompletedCellulitis | Folliculitis | Abscesses | Community-Acquired MRSA InfectionsUnited States
-
University Health Network, TorontoCompleted
-
B. Braun Medical SATerminatedMRSA - Methicillin Resistant Staphylococcus Aureus Infection | MRSA ColonizationSpain