Use of Ointments in Prevention of Catheter Related Infections in PD

End Stage Renal Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00400595
• Other study ID #: 05-0850-AE
• Status: Completed
• Phase: Phase 4
• First received: November 15, 2006
• Last updated: March 16, 2015
• Start date: February 2006
• Est. completion date: June 2010

Study information

• Verified date: March 2015
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 2010
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Catheter-Related Infections
• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

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

Locations

Country	Name	City	State
Canada	Scarborough General Hospital	Toronto	Ontario
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (1)

McQuillan RF, Chiu E, Nessim S, Lok CE, Roscoe JM, Tam P, Jassal SV. A randomized controlled trial comparing mupirocin and polysporin triple ointments in peritoneal dialysis patients: the MP3 Study. Clin J Am Soc Nephrol. 2012 Feb;7(2):297-303. doi: 10.22 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is the time to first catheter related infection.		2Yrs	No
Secondary	Removal of the catheter to prevent or halt progression of a catheter related infection		2 yrs	No
Secondary	Hospitalizations related to catheter related infection		2 yrs	No
Secondary	Death due to catheter-related infection		2 yrs	No
Secondary	All-cause mortality		2yrs	Yes
Secondary	Technique failure (i.e. transfer to hemodialysis)		2yrs	No
Secondary	Mupirocin or Polysporin Triple resistance		2yrs	Yes