Clinical trial NCT00108160
Conditions: Staphylococcal Infections
Keywords: mupirocin prevention and control s. aureus
Sponsor: US Department of Veterans Affairs
Start date: 2005-04-01; Completion date: 2012-08-01
Enrollment: 146 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if mupirocin 2% in polyethylene glycol (PEG) ointment \[Treatment Arm\] is effective in preventing moderate to severe re-infection with Staphylococcus aureus compared with treatment with polyethylene glycol (PEG) ointment \[Placebo Arm\].

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, three times 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 ointment was effective in decolonizing older chronically ill nursing home residents of S. aureus when compared with placebo ointment. 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 ointment 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 2% polyethylene glycol (PEG) ointment \[Treatment Arm\] or polyethylene glycol (PEG) ointment \[Placebo Arm\] for 14 days every 3 months. The effect of these two regimens on S. aureus re-infection, re-colonization, and development of mupirocin resistance will be assessed.

Arms: arm 1: Treatment arm or active comparator \[mupirocin 2% polyethylene glycol (PEG) ointment\] will be compared with its placebo comparator \[polyethylene glycol (PEF) in patients with a prior history of S. aureus infection. Drug or placebo will be applied topically to nares and/or wounds twice daily for 14 days at 3 month intervals for up to 18 months arm 2: Treatment arm or active comparator \[mupirocin 2% polyethylene glycol (PEG) ointment\] will be compared with its placebo comparator \[polyethylene glycol (PEF) in patients with a prior history of S. aureus infection. Drug or placebo will be applied topically to nares and/or wounds twice daily for 14 days at 3 month intervals for up to 18 months
Interventions: intervention 1: Mupirocin Ointment [Treatment] intervention 2: Polyethylene Glycol Ointment [Placebo]
Intervention descriptions: intervention 1: The impact of the treatment arm versus placebo arm on development of new (recurrent) S. aureus infection will be assessed as the primary end point. Change in S. aureus strains (MSSA versus MRSA) will be assessed as the secondary end point. intervention 2: The impact of the treatment arm versus placebo arm on development of S. aureus re-infections will be assessed as the primary end point. Change in S. aureus strains (MSSA versus MRSA) will be assessed as the secondary end point.

Protocol documents: