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Completed

NCT Number: NCT00156377

Prophylaxis With Intranasal Mupirocin for Prevention of S. Aureus Infections

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Institute of Medical Microbiology, University Hospital of Muenster

Münster, 48149, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mupirocin

Drug

Primary outcomes

  1. Staphylococcus aureus infection any time after 5 days of mupirocin ointment

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

University Hospital Muenster

Other

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

Investigation of the Influence of Intranasal Mupirocin on the Prevalence of S. Aureus Nosocomial Infections by Eradication of Intranasal S. Aureus

Important dates

Study start
2002
First posted
Sep 12, 2005
Registry last updated
May 25, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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