Staphylococcal InfectionsPhase 4NCT00108160
Preventing Staphylococcal (Staph) Infection
A Phase 4 study testing Mupirocin Ointment [Treatment] in people with Staphylococcal Infections, run by US Department of Veterans Affairs at 1 site in United States.
Trial 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]. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Staphylococcal Infections
- What is being tested?
- Mupirocin Ointment [Treatment]
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Aug 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, 48113
About this study
Official title: Intermittent Mupirocin to Prevent Staphylococcal Infection
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].
Read the 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.
- Conditions
- Staphylococcal Infections
- Being tested
- Mupirocin Ointment [Treatment], Polyethylene Glycol Ointment [Placebo]
- Keywords
- mupirocin, prevention and control, s. aureus
- Medical subject headings
- Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mupirocin Ointment [Treatment]Drug
Also called Bactroban ointment, Mupirocin 2% in Polyethylene Glycol (PEG) Ointment
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.
Polyethylene Glycol Ointment [Placebo]Drug
Also called PEG Ointment
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.
| Study group | Role | What they receive |
|---|---|---|
| Mupirocin Ointment [Treatment] | Active comparator | 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 Receives: Drug: Mupirocin Ointment [Treatment] |
| Polyethylene Glycol Ointment [Placebo] | Placebo comparator | 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 Receives: Drug: Polyethylene Glycol Ointment [Placebo] |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 18 months
Secondary outcomes (1)
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2005 (estimated)
- Study startApr 2005
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Staphylococcal InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Collaborators
- University of Michigan, Trinity Health Michigan
- Responsible party
- Sponsor
- Investigators
- Suzanne Bradley, MD, Principal investigator, VA Ann Arbor Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00108160
- Sponsor's protocol ID
- CLNB-001-04S
- Status last verified
- Mar 2014
- First submitted
- 14 Apr 2005
- Last updated
- 16 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Mupirocin to Prevent Staphylococcal Infection
- ClinicalTrials.gov ID
- NCT00108160
- Acronym / sponsor ID
- CLNB-001-04S
- Conditions
- Staphylococcal Infections
- Keywords
- mupirocin, prevention and control, s. aureus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Collaborators
- University of Michigan, Trinity Health Michigan
- Study start
- Apr 2005
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 15 Apr 2005 (estimated)
- Results
- Posted 4 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mupirocin Ointment [Treatment] | Active comparator | Drug: Mupirocin Ointment [Treatment]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 |
| Polyethylene Glycol Ointment [Placebo] | Placebo comparator | Drug: Polyethylene Glycol Ointment [Placebo]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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mupirocin Ointment [Treatment]Also: Bactroban ointment, Mupirocin 2% in Polyethylene Glycol (PEG) OintmentThe 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. | Drug | Mupirocin Ointment [Treatment] |
| Polyethylene Glycol Ointment [Placebo]Also: PEG OintmentThe 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. | Drug | Polyethylene Glycol Ointment [Placebo] |
Primary outcome
Re-infection With S. Aureus
Time frame: 18 months
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)
1 secondary outcome
Acquisition of New S. Aureus Strains
Time frame: 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanne Bradley, MD principal investigator
VA Ann Arbor Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mupirocin Ointment [Treatment] in people with Staphylococcal Infections, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Re-infection With S. Aureus (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2014.