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Prophylaxis With Intranasal Mupirocin for Prevention of S. Aureus Infections

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT00156377
First received: September 8, 2005
Last updated: May 24, 2010
Last verified: September 2005
  Purpose

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
Cross Infection
Staphylococcal Infections
Drug: Mupirocin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Investigation of the Influence of Intranasal Mupirocin on the Prevalence of S. Aureus Nosocomial Infections by Eradication of Intranasal S. Aureus

Resource links provided by NLM:


Further study details as provided by University Hospital Muenster:

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

Estimated Enrollment: 1200
Study Start Date: November 2002
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00156377

Locations
Germany
Institute of Medical Microbiology, University Hospital of Muenster
Muenster, Germany, 48149
Sponsors and Collaborators
University Hospital Muenster
GlaxoSmithKline
Investigators
Principal Investigator: Christof von Eiff, MD University Hospital of Muenster, Institute of Medical Microbiology
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00156377     History of Changes
Other Study ID Numbers: 4710F-186
Study First Received: September 8, 2005
Last Updated: May 24, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Muenster:
Mupirocin
Staphylococcus aureus
Nasal Cavity
Preventive measures

Additional relevant MeSH terms:
Communicable Diseases
Cross Infection
Infection
Staphylococcal Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Mupirocin
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Synthesis Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014