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| Sponsors and Collaborators: |
Department of Veterans Affairs University of Michigan St. Joseph's Healthcare |
|---|---|
| Information provided by: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00108160 |
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 IV |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Intermittent Mupirocin to Prevent Staphylococcal Infection |
| Estimated Enrollment: | 198 |
| Study Start Date: | April 2005 |
| Estimated Study Completion Date: | March 2010 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
Drug: polyethylene glycol ointment
vehicle for mupirocin ointment
|
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 |
Inclusion Criteria:
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.
Exclusion Criteria:
Contacts and Locations| Contact: Suzanne Bradley, MD | sbradley@umich.edu | |
| Contact: Carol A Kauffman, MD | (734) 761-7984 | ckauff@med.umich.edu |
| United States, Michigan | |
| VA Ann Arbor Healthcare System | Recruiting |
| Ann Arbor, Michigan, United States, 48113 | |
| Contact: Suzanne Bradley, MD sbradley@umich.edu | |
| Principal Investigator: Suzanne Bradley, MD | |
| Principal Investigator: | Suzanne Bradley, MD | VA Ann Arbor Healthcare System |
More Information
| Responsible Party: | Department of Veterans Affairs ( Bradley, Suzanne - Principal Investigator ) |
| Study ID Numbers: | CLNB-001-04S |
| Study First Received: | April 14, 2005 |
| Last Updated: | May 18, 2009 |
| ClinicalTrials.gov Identifier: | NCT00108160 History of Changes |
| Health Authority: | United States: Federal Government |
|
mupirocin prevention and control s. aureus |
|
Bacterial Infections Anti-Infective Agents Anti-Bacterial Agents |
Staphylococcal Infections Gram-Positive Bacterial Infections Mupirocin |
|
Bacterial Infections Communicable Diseases Anti-Infective Agents Mupirocin Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Infection |
Pharmacologic Actions Staphylococcal Infections Protein Synthesis Inhibitors Anti-Bacterial Agents Gram-Positive Bacterial Infections Therapeutic Uses |
