Bacitracin Eye Ointment |
AK-Tracin; Ocu-Tracin |
Clinical Trial: Preventing Staphylococcal (Staph) Infection
This study is not yet open for patient recruitment.
|
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 | Treatment or Intervention | Phase |
|---|---|---|
| Staphylococcal Infections | Drug: mupirocin 2% PEG ointment Drug: polyethylene glycol ointment | Phase IV |
MedlinePlus related topics: Staphylococcal Infections
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Intermittent Mupirocin to Prevent Staphylococcal Infection
Study start: April 2005; Expected completion: March 2008
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 above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- All patients hospitalized at Ann Arbor and Pittsburgh VA Medical Centers who have 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, and the Infectious Diseases Consultation Service.
- 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.
Location and Contact Information
Michigan
VA Ann Arbor Healthcare System, Ann Arbor, Michigan, 48105, United States
Suzanne Bradley, M.D., Principal Investigator
More Information
Record last reviewed: April 2005
Last Updated: April 14, 2005
Record first received: April 14, 2005
ClinicalTrials.gov Identifier: NCT00108160
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-05-03
Source: ClinicalTrials.gov
Cache Date: May 4, 2005

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