Preventing Staphylococcal (Staph) Infection
The purpose of this study is to determine if intermittent mupirocin treatment is effective in preventing recurrence of moderate to severe staph infection.
Drug: mupirocin 2% polyethylene glycol
Drug: polyethylene glycol
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
|Official Title:||Intermittent Mupirocin to Prevent Staphylococcal Infection|
- Staphylococcal Re-infection [ Time Frame: 18 months ] [ Designated as safety issue: No ]During the study, patients with prior well-documented infections with Staphylococcus aureus who developed new signs and symptoms of infection, met standardized clinical criteria for infection, and had S. aureus isolated on culture were considered to have a staphylococcal re-infection. The patient's S. aureus re-infection could occur at a new anatomic site or recur at the previously described site of infection noted on enrollment.
- Acquisition New Staphylococcal Strain [ Time Frame: 18 months ] [ Designated as safety issue: No ]Infecting isolates of S. aureus, MRSA versus MSSA, were assessed pre and post study drug to see if they differed from baseline infecting strains. The anatomic sites of infection were also compared pre and post study drug to see if new infection versus relapse of old infection occurred.
|Study Start Date:||April 2005|
|Study Completion Date:||August 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Active Comparator: S. aureus decolonization
Drug [mupirocin 2% polyethylene glycol (PEG)] vs placebo (PEG alone) are applied topically to nares and/or wounds twice daily for 14 days at regular intervals (~ 3 month intervals) for up to 18 months in patients with a known history of S. aureus infection
Drug: mupirocin 2% polyethylene glycol
Topical antibiotic applied to nares and wounds (if present) for 14 days twice daily. Course repeated every 3 months for up to 18 months.
Other Name: BactrobanDrug: polyethylene glycol
vehicle for mupirocin ointment
Other Name: PEG
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.
|United States, Michigan|
|VA Ann Arbor Healthcare System|
|Ann Arbor, Michigan, United States, 48113|
|Principal Investigator:||Suzanne Bradley, MD||VA Ann Arbor Healthcare System|