Official Title: “A Randomized Controlled Double Blind Study Using Mupirocin Versus Polysporin Triple for the Prevention of Catheter-Related Infections in Patients Treated With Peritoneal Dialysis”

Peritoneal dialysis (PD) is used for the treatment of end-stage renal disease in approximately 25% of patients requiring dialysis in Canada. The most common complication is bacterial infection or 'peritonitis'. Peritonitis causes severe acute abdominal pain and may lead to failure of peritoneal dialysis treatment, hospitalization or death, particularly if left untreated. Amongst the strategies used to prevent peritonitis, patients are instructed on the regular use of a prophylactic ointment around the point where the catheter exits from the body. At the present time most centers in Canada routinely prescribe mupirocin ointment for use at the exit site, however newer ointments have become available. One such ointment is Polysporin Triple. The aim of this study is to determine if catheter related infections can be significantly reduced by the routine application of Polysporin Triple in comparison to mupirocin ointment. A multi-centre, randomized, double blind, controlled study is proposed.

Participants will be randomized to either mupirocin or Polysporin Triple and followed for 18 months or until the first catheter related infection, death or catheter removal. The difference in catheter related infection rates will be compared between the two groups. We anticipate the results of this study will allow clinicians to prescribe the ointment most likely to reduce infections. By doing so this will reduce the complication rate associated with peritoneal dialysis and, ultimately improve survival.

Study Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: March 2009

Peritoneal dialysis (PD) is used for the treatment of end-stage renal disease in approximately 25% of patients requiring dialysis in Canada. The most common PD related complication is infective peritonitis, a syndrome of acute pain, cloudy peritoneal dialysate, and infection. Although many cases of peritonitis can be treated as an outpatient, recurrent or unresolving infections can result in fibrotic changes in the peritoneal membrane, catheter removal or patient death. Gram positive organisms are amongst the commonest causes of PD peritonitis; however, recent trends show an increasing rate of gram negative and fungal infections. Strategies to prevent peritonitis include the use of prophylactic topical mupirocin at the site where the PD catheter exits from the abdominal wall. Despite this and other innovations peritonitis is still diagnosed, on average, in one patient out of every 24 patients followed for a month. The aim of this study is to determine if the incidence of catheter related infections (exit site infection, tunnel infection or peritonitis) is significantly reduced by the routine application of Polysporin Triple in comparison to mupirocin ointment.A multi-centre randomized double blind, controlled study is proposed.

Polysporin Triple will be compared against the current standard of care. All patients currently being treated with, or starting onto, peritoneal dialysis will be eligible.

Participants will be randomized to one of two treatment arms (mupirocin; Polysporin Triple) and stratified according to a) centre b) vintage (incident versus prevalent), and c) type of PD (chronic ambulatory peritoneal dialysis vs. automated PD). Patients will be followed for 18 months or until the first catheter related infection, death or catheter removal due to technique failure. Catheter related infections will be strictly defined using current guidelines and categorized into exit site infections, infective peritonitis or tunnel infections.

Intervention(s) in this Clinical Trial

• Drug: Mupirocin ointment
  • topical ointment (already in widespread clinical use)
• Drug: Polysporin Triple

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Polysporin tRIPLE ointment (topical ointment in widespread use for other skin lesions)
• Active Comparator: 2
  • Mupirocin

Primary Measures

• The primary endpoint is the time to first catheter related infection.
  • Time Frame: 2Yrs
    Safety Issue?: No

Secondary Measures

• Removal of the catheter to prevent or halt progression of a catheter related infection
  • Time Frame: 2 yrs
    Safety Issue?: No
• Hospitalizations related to catheter related infection
  • Time Frame: 2 yrs
    Safety Issue?: No
• Death due to catheter-related infection
  • Time Frame: 2 yrs
    Safety Issue?: No
• All-cause mortality
  • Time Frame: 2yrs
    Safety Issue?: Yes
• Technique failure (i.e. transfer to hemodialysis)
  • Time Frame: 2yrs
    Safety Issue?: No
• Mupirocin or Polysporin Triple resistance
  • Time Frame: 2yrs
    Safety Issue?: Yes

Inclusion Criteria:

• 1. Able and willing to provide informed consent*
• 2. Age over 18 years
• 3. Has a peritoneal dialysis catheter in situ and
• Is established on PD for more than 3 months (prevalent patients)
• Is undergoing training for or has initiated PD within the last 3 months (incident patients)
• 4. Medically stable (as defined by primary nephrologist)
• 5. Regularly applying mupirocin ointment to catheter exit site

Exclusion Criteria:

• 1. Presence of acute renal failure
• 2. Catheter related infection at the time of recruitment or within the previous 3 months
• 3. Use of an oral or IV antibiotic at the time of randomization or within the previous 1 week.
• 4. Known allergy to any component of gentamicin or mupirocin

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University Health Network, Toronto

Overall Clinical Trial Officials and Contacts

Vanita Jassal, MD Principal Investigator University Health Network, Toronto  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00400595

Study ID Number: 05-0850-AE

ClinicalTrials.gov Identifier: NCT00400595

Health Authority: Canada: Health Canada