Use of Ointments in Prevention of Catheter Related Infections in PD

NCT00400595 | Completed Phase 4 DMC

• 1 other identifier: 05-0850-AE
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

End Stage Renal Disease

Keywords

peritonitis; catheter related infection; exit site ointments; mupirocin; Polysporin Triple

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is the time to first catheter related infection.

  2Yrs

Secondary Outcomes (6)

• Removal of the catheter to prevent or halt progression of a catheter related infection

  2 yrs

• Hospitalizations related to catheter related infection

  2 yrs

• Death due to catheter-related infection

  2 yrs

• All-cause mortality

  2yrs

• Technique failure (i.e. transfer to hemodialysis)

  2yrs

Study Arms (2)

1

EXPERIMENTAL

Polysporin tRIPLE ointment (topical ointment in widespread use for other skin lesions)

Drug: Polysporin Triple

2

ACTIVE COMPARATOR

Mupirocin

Drug: Mupirocin ointment

Interventions

Mupirocin ointment DRUG

topical ointment (already in widespread clinical use)

2

Polysporin Triple DRUG

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to provide informed consent\*
• Age over 18 years
• 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)
• Medically stable (as defined by primary nephrologist)
• Regularly applying mupirocin ointment to catheter exit site

You may not qualify if:

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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (2)

Scarborough General Hospital

Toronto, Ontario, M1P 2V5, Canada

Location

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (2)

• 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: 10.2215/CJN.07970811. Epub 2011 Dec 1.

  PMID: 22134627 RESULT

• Jassal SV, Lok CE; MP3 Study Group. A randomized controlled trial comparing mupirocin versus Polysporin Triple for the prevention of catheter-related infections in peritoneal dialysis patients (the MP3 study). Perit Dial Int. 2008 Jan-Feb;28(1):67-72.

  PMID: 18178950 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic; Peritonitis; Catheter-Related Infections

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraabdominal Infections; Infections; Peritoneal Diseases; Digestive System Diseases

Study Officials

• Vanita Jassal, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 15, 2006
• First Posted: November 17, 2006
• Study Start: February 1, 2006
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2010
• Last Updated: March 18, 2015

Record last verified: 2015-03

Locations

CA (2)