Preventing Staphylococcal (Staph) Infection
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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 |
- Recurrent Staphylococcal Infection [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- 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 |
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| United States, Michigan | |
| VA Ann Arbor Healthcare System | |
| Ann Arbor, Michigan, United States, 48113 | |
| 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