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Sponsors and Collaborators: |
University Hospital Muenster GlaxoSmithKline |
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Information provided by: | University Hospital Muenster |
ClinicalTrials.gov Identifier: | NCT00156377 |
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.
Condition | Intervention | Phase |
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Cross Infection Staphylococcal Infections |
Drug: Mupirocin |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Investigation of the Influence of Intranasal Mupirocin on the Prevalence of S. Aureus Nosocomial Infections by Eradication of Intranasal S. Aureus |
Estimated Enrollment: | 1200 |
Study Start Date: | November 2002 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
Institute of Medical Microbiology, University Hospital of Muenster | |
Muenster, Germany, 48149 |
Principal Investigator: | Christof von Eiff, MD | University Hospital of Muenster, Institute of Medical Microbiology |
Study ID Numbers: | 4710F-186 |
Study First Received: | September 8, 2005 |
Last Updated: | September 13, 2005 |
ClinicalTrials.gov Identifier: | NCT00156377 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Mupirocin Staphylococcus aureus Nasal Cavity Preventive measures |
Bacterial Infections Anti-Infective Agents Anti-Bacterial Agents Staphylococcal Infections |
Gram-Positive Bacterial Infections Mupirocin Cross Infection |
Bacterial Infections Communicable Diseases Anti-Infective Agents Mupirocin Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Infection |
Pharmacologic Actions Staphylococcal Infections Protein Synthesis Inhibitors Anti-Bacterial Agents Gram-Positive Bacterial Infections Therapeutic Uses Cross Infection |