Official Title: “Intermittent Mupirocin to Prevent Staphylococcal Infection”

The purpose of this study is to determine if intermittent mupirocin treatment is effective in preventing recurrence of moderate to severe staph infection.

Study Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: March 2009

Treatment of staphylococcal carriage with the topical antibiotic, mupirocin, has led to decreased infections in some hemodialysis patients and intensive care unit (ICU) patients.

However, most of these studies were not placebo controlled and only certain subsets of patients benefited. Relapse of colonization, generally within 90 days after treatment is stopped, presumably with increased risk of infection, approaches 50%. Continuous use of mupirocin on daily, thrice weekly, or weekly basis has resulted in increased resistance to the drug. Despite this lack of evidence, the use of mupirocin has become commonplace because it is perceived as an effective and simple means to prevent infection. In a National Institutes on Aging/Claude D. Pepper Older Americans Independence Center (NIA/OAIC)-sponsored proposal, the investigators found that a 2 week treatment regimen with mupirocin was effective in decolonizing older chronically ill nursing home residents of S. aureus when compared with placebo. Decolonization began to decline by 3 months post-treatment, and resistance occurred only once in 52 treated patients. That study was not powered to detect differences in infection between the 2 study groups; the end point was eradication of colonization. However, a trend towards reduction in staphylococcal infection with mupirocin was seen. In addition, there were more therapeutic failures in residents who were colonized with methicillin-resistant S. aureus (MRSA) than methicillin-sensitive S. aureus (MSSA). The investigators hypothesize that intermittent treatment with mupirocin every 3 months may be an effective means of preventing recolonization and infection with S. aureus. The investigators propose to study a patient population that has already had treatment for severe S. aureus infection and is at significant risk for a subsequent infection. Patients will receive mupirocin or placebo for 14 days every 3 months. The effect of these two regimens on S.

aureus infection, re-colonization, and development of mupirocin resistance will be assessed.

Intervention(s) in this Clinical Trial

• Drug: mupirocin 2% PEG ointment
  • Topical antibiotic applied to nares and wounds (if present) for 14 days bid. Course repeated every 3 months for up to 18 months.
• Drug: polyethylene glycol ointment
  • vehicle for mupirocin ointment

Arms, Groups and Cohorts in this Clinical Trial

• Other: 1
  • mupirocin vs its inactive vehicle are compared in patients with recent history of S. aureus infection

Primary Measures

• Recurrent Staphylococcal Infection
  • Time Frame: 18 months
    Safety Issue?: No

Secondary Measures

• Acquisition New Staphylococcal Strain
  • Time Frame: 18 months
    Safety Issue?: No

Inclusion Criteria:

• All patients who receive care at Ann Arbor VA Medical Center, University of Michigan
• Medical Center, or St. Joseph Mercy Hospital, Ypsilanti who have been hospitalized for documented S. aureus infection will be eligible for enrollment. Staphylococcal infections may be community or hospital-acquired. Patients with S. aureus infection will be identified on a daily basis with the assistance of the Infection Control
• Practitioner, the Clinical Microbiology Laboratory, the Infectious Diseases
• Consultation Services, and ID physicians caring for patients in their offices.
• Patients will provide written informed consent. The patient's guardian or next of kin will be contacted for informed consent in the event that the patient is incapable of doing so.

Exclusion Criteria:

• Patients who are unable to cooperate with treatment or followup.
• Patients who are not likely to survive beyond one month or those who are transferred back to another acute care hospital.
• Patients who require treatment with rifampin will be excluded since this drug is effective in decolonization of some staphylococcal carriers.
• Patients with known hypersensitivity to mupirocin ointment or polyethylene glycol base.
• Patients with ulcers obviously related to pressure will be excluded because they are frequently large, difficult to keep clean, and infections are difficult to diagnose.
• Patients with small vascular or neuropathic ulcers < 3 cm in circumference and < 2 cm in depth may be enrolled.
• Pregnant women.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Department of Veterans Affairs

Overall Clinical Trial Officials and Contacts

Suzanne Bradley, MD Principal Investigator VA Ann Arbor Healthcare System  

Overall Contact: Suzanne Bradley, MD  sbradley@umich.edu

Information obtained from ClinicalTrials.gov on November 18, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00108160

Study ID Number: CLNB-001-04S

ClinicalTrials.gov Identifier: NCT00108160

Health Authority: United States: Federal Government