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| autoid | 103 |
| crg_id | CRG020600039 |
| titleoftrial | A randomized controlled double blind study using Mupirocin versus Polysporin Triple for the prevention of catheter-related infections in patients treated with peritoneal dialysis |
| acronymnoftrial | Oint-1 |
| website | http:// |
| identificationno | |
| leadprefix | Dr |
| leadsurname | Jassal |
| leadgivennames | Sarbjit Vanita |
| leadposition | Assistant Professor |
| leaddepartment | Medicine |
| leadorganisation | University Health Network |
| leadaddress | 200 Elizabeth St, 8N-857, Toronto, ON M5G 2C4 Canada |
| leademail | vanita.jassal@uhn.on.ca |
| leadphone | +1 416 340 3196 |
| leadfax | +1 416 340 4999 |
| leadsuffix | |
| contactprefix | |
| contactsurname | Gordon |
| contactgivennames | Debra |
| contactposition | Research Coordinator |
| contactdepartment | |
| contactorganisation | University Health Network |
| contactaddress | 200 Elizabeth St, 8N-857, Toronto, ON M5G 2C4 |
| contactemail | debra.gordon@uhn.on.ca |
| contactphone | +1 416 340 4800 extn 6362 |
| contactfax | +1 416 340 4999 |
| funding | |
| otherfunding | awaiting funding decision |
| fundingnameofsponsors | |
| ethicsapproval | yes |
| studytype | randomised |
| studytype_other | |
| groupassignment | parallel |
| blinding_patients | yes |
| blinding_investigators | yes |
| blinding_outcomes | no |
| blinding_analysts | yes |
| proposedstart | July 2006 |
| actualstart | Feb 2006 |
| proposedcompletiondate | Aug 2008 |
| actualcompletiondate | |
| multi_center_study | yes |
| numberofcentres | 4 |
| multi_national_study | no |
| countrycentres | Canada |
| researchquestion | To compare the time to the first catheter-related infection when prophylactic topical Polysporin Triple versus mupirocin ointment is used at the peritoneal catheter exit site in patients with end-stage renal disease maintained on peritoneal dialysis. |
| study_status_recruitment | ongoing |
| study_status_recruitment_follow | ongoing |
| healthcarecondition | peritoneal dialysis |
| intervention1 | polysporin triple ointment |
| intervention2 | mupirocin |
| intervention3 | |
| intervention4 | |
| participants_gender | both |
| participants_other | adults |
| age | 18-N/A |
| totalrecruitment | 200 |
| inclusion | 1. Able and willing to provide informed consent*
2. Age over 18 years 3. Has a peritoneal dialysis catheter in situ and a. Is established on PD for more than 3 months (prevalent patients) b. 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 | 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 Polysporin Triple or mupirocin 5. Scheduled for living donor transplant surgery within 6 months of study date |
| primaryoutcomes | The primary endpoint is the time to first catheter related infection. This infection will be a composite endpoint that includes one or more of the following PD catheter-related infections a) exit site infection, b) tunnel infection, and c) PD peritonitis. Definitions of these infections will be based on the Canada Communicable Disease Report infection control and the International Society of Peritoneal Dialysis Guidelines. |
| secondaryoutcomes | 1. Removal of the catheter to prevent or halt progression of a catheter related infection
2. Hospitalizations related to catheter related infection 3. Death due to catheter-related infection 4. All-cause mortality 5. Technique failure (i.e. transfer to hemodialysis) 6. Mupirocin or Polysporin Triple resistance |
| reference |