Preventing Staphylococcal (Staph) Infection
Information source: Department of Veterans Affairs
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Staphylococcal Infections
Intervention: mupirocin 2% PEG ointment (Drug); polyethylene glycol ointment (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Department of Veterans Affairs Official(s) and/or principal investigator(s):
Suzanne Bradley, MD, Principal Investigator, Affiliation: VA Ann Arbor Healthcare System
Overall contact:
Suzanne Bradley, MD, Email: sbradley@umich.edu
Summary
The purpose of this study is to determine if intermittent mupirocin treatment is effective
in preventing recurrence of moderate to severe staph infection.
Clinical Details
Official title: Intermittent Mupirocin to Prevent Staphylococcal Infection
Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Recurrent Staphylococcal Infection
Secondary outcome: Acquisition New Staphylococcal Strain
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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 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.
Locations and Contacts
Suzanne Bradley, MD, Email: sbradley@umich.edu
VA Ann Arbor Healthcare System, Ann Arbor, Michigan 48113, United States; Recruiting
Suzanne Bradley, MD, Email: sbradley@umich.edu
Suzanne Bradley, MD, Principal Investigator
Additional Information
Starting date: April 2005
Ending date: March 2010
Last updated: May 18, 2009
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