Preventing Staphylococcal (Staph) Infection

This study has been completed.
Sponsor:
Collaborators:
University of Michigan
St. Joseph's Health Care London
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00108160
First received: April 14, 2005
Last updated: February 1, 2013
Last verified: February 2013
  Purpose

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


Condition Intervention Phase
Staphylococcal Infections
Drug: mupirocin 2% PEG ointment
Drug: polyethylene glycol ointment
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Intermittent Mupirocin to Prevent Staphylococcal Infection

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Recurrent Staphylococcal Infection [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Acquisition New Staphylococcal Strain [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 147
Study Start Date: April 2005
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1
mupirocin vs its inactive vehicle are compared in patients with recent history of S. aureus infection
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.
Other Name: Bactroban
Drug: polyethylene glycol ointment
vehicle for mupirocin ointment

Detailed Description:

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, we 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). We hypothesize that intermittent treatment with mupirocin every 3 months may be an effective means of preventing recolonization and infection with S. aureus. We 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 follow-up.
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00108160

Locations
United States, Michigan
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, United States, 48113
Sponsors and Collaborators
University of Michigan
St. Joseph's Health Care London
Investigators
Principal Investigator: Suzanne Bradley, MD VA Ann Arbor Healthcare System
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00108160     History of Changes
Other Study ID Numbers: CLNB-001-04S
Study First Received: April 14, 2005
Last Updated: February 1, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
mupirocin
prevention and control
s. aureus

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

ClinicalTrials.gov processed this record on May 19, 2013