search
Back to results

Preventing Staphylococcal (Staph) Infection

Primary Purpose

Staphylococcal Infections

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Mupirocin Ointment [Treatment]
Polyethylene Glycol Ointment [Placebo]
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Staphylococcal Infections focused on measuring mupirocin, prevention and control, s. aureus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 Infectious Diseases 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.

Sites / Locations

  • VA Ann Arbor Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Mupirocin Ointment [Treatment]

Polyethylene Glycol Ointment [Placebo]

Arm Description

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

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

Outcomes

Primary Outcome Measures

Re-infection With S. Aureus
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 re-infection with S. aureus. The number of S. aureus re-infections were compared in the mupirocin ointment (Treatment Arm) versus polyethylene glycol ointment (Placebo Arm) for all participants enrolled in the study and in participants who completed each study time point (visit)

Secondary Outcome Measures

Acquisition of New S. Aureus Strains
In the Mupirocin Ointment (Treatment) and Polyethylene Glycol (Placebo) Arms, S. aureus isolates (MSSA or MRSA) that caused infection prior to enrollment in the study were compared with S. aureus infecting isolates (MSSA or MRSA) that occurred during the study (re-infections). Infecting isolates that were found to be MRSA at enrollment and MRSA during the study were considered to be the same strain; this same strain definition was also applied to MSSA isolates. Infecting isolates that changed from MRSA at enrollment to MSSA during the study (or vice versa) were considered to be different strains.

Full Information

First Posted
April 14, 2005
Last Updated
March 20, 2014
Sponsor
US Department of Veterans Affairs
Collaborators
University of Michigan, Saint Joseph Mercy Health System
search

1. Study Identification

Unique Protocol Identification Number
NCT00108160
Brief Title
Preventing Staphylococcal (Staph) Infection
Official Title
Intermittent Mupirocin to Prevent Staphylococcal Infection
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs
Collaborators
University of Michigan, Saint Joseph Mercy Health System

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Staphylococcal Infections
Keywords
mupirocin, prevention and control, s. aureus

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
146 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mupirocin Ointment [Treatment]
Arm Type
Active Comparator
Arm Description
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 Title
Polyethylene Glycol Ointment [Placebo]
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Mupirocin Ointment [Treatment]
Other Intervention Name(s)
Bactroban ointment, Mupirocin 2% in Polyethylene Glycol (PEG) Ointment
Intervention Description
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 Type
Drug
Intervention Name(s)
Polyethylene Glycol Ointment [Placebo]
Other Intervention Name(s)
PEG Ointment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Re-infection With S. Aureus
Description
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 re-infection with S. aureus. The number of S. aureus re-infections were compared in the mupirocin ointment (Treatment Arm) versus polyethylene glycol ointment (Placebo Arm) for all participants enrolled in the study and in participants who completed each study time point (visit)
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Acquisition of New S. Aureus Strains
Description
In the Mupirocin Ointment (Treatment) and Polyethylene Glycol (Placebo) Arms, S. aureus isolates (MSSA or MRSA) that caused infection prior to enrollment in the study were compared with S. aureus infecting isolates (MSSA or MRSA) that occurred during the study (re-infections). Infecting isolates that were found to be MRSA at enrollment and MRSA during the study were considered to be the same strain; this same strain definition was also applied to MSSA isolates. Infecting isolates that changed from MRSA at enrollment to MSSA during the study (or vice versa) were considered to be different strains.
Time Frame
18 months
Other Pre-specified Outcome Measures:
Title
S. Aureus Re-infections (New or Recurrent)
Description
The anatomic site of each S. infection at enrollment and S. aureus re-infection that occurred during the study was compared. S. aureus isolated from a different site of infection than at baseline was considered to represent a new infection. Isolation of S. aureus from the same site as the baseline infection was considered to represent a recurrent infection.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Infectious Diseases 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne Bradley, MD
Organizational Affiliation
VA Ann Arbor Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Ann Arbor Healthcare System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48113
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Preventing Staphylococcal (Staph) Infection

We'll reach out to this number within 24 hrs