End Stage Renal DiseasePhase 4NCT00400595
Use of Ointments in Prevention of Catheter Related Infections in PD
A Phase 4 study testing Mupirocin ointment and Polysporin Triple in people with End Stage Renal Disease, run by University Health Network, Toronto at 2 sites in Canada.
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'. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Mupirocin ointment and Polysporin Triple
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesCanada
- Study dates
- Feb 2006to Jun 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Scarborough General Hospital
Toronto, Ontario, M1P 2V5
University Health Network
Toronto, Ontario, M5G 2C4
About this study
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.
Read the detailed 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.
- Conditions
- End Stage Renal Disease
- Being tested
- Mupirocin ointment, Polysporin Triple
- Keywords
- peritonitis, catheter related infection, exit site ointments, mupirocin, Polysporin Triple
- Medical subject headings
- Kidney Failure, Chronic, Peritonitis, Catheter-Related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mupirocin ointmentDrug
topical ointment (already in widespread clinical use)
Polysporin TripleDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Polysporin tRIPLE ointment (topical ointment in widespread use for other skin lesions) Receives: Drug: Polysporin Triple |
| 2 | Active comparator | Mupirocin Receives: Drug: Mupirocin ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the time to first catheter related infection.
Measured: 2Yrs
Secondary outcomes (6)
Removal of the catheter to prevent or halt progression of a catheter related infection
Measured: 2 yrs
Hospitalizations related to catheter related infection
Measured: 2 yrs
Death due to catheter-related infection
Measured: 2 yrs
All-cause mortality
Measured: 2yrs
Technique failure (i.e. transfer to hemodialysis)
Measured: 2yrs
Mupirocin or Polysporin Triple resistance
Measured: 2yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2006 (estimated)
- Study startFeb 2006
- Primary completionJun 2009
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vanita Jassal, University Health Network, Toronto
- Investigators
- Vanita Jassal, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00400595
- Sponsor's protocol ID
- 05-0850-AE
- Status last verified
- Mar 2015
- First submitted
- 15 Nov 2006
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22134627Jassal 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.
PubMed 18178950
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00400595
- Acronym / sponsor ID
- 05-0850-AE
- Conditions
- End Stage Renal Disease
- Keywords
- peritonitis, catheter related infection, exit site ointments, mupirocin, Polysporin Triple
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 17 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Polysporin TriplePolysporin tRIPLE ointment (topical ointment in widespread use for other skin lesions) |
| 2 | Active comparator | Drug: Mupirocin ointmentMupirocin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Able and willing to provide informed consent*
- Age over 18 years
- Has a peritoneal dialysis catheter in situ and
- Medically stable (as defined by primary nephrologist)
- Regularly applying mupirocin ointment to catheter exit site
Key exclusion criteria (4 listed)
- 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
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 ointmenttopical ointment (already in widespread clinical use) | Drug | 2 |
| Polysporin Triple | Drug | 1 |
Primary outcome
The primary endpoint is the time to first catheter related infection.
Time frame: 2Yrs
6 secondary outcomes
Removal of the catheter to prevent or halt progression of a catheter related infection
Time frame: 2 yrs
Hospitalizations related to catheter related infection
Time frame: 2 yrs
Death due to catheter-related infection
Time frame: 2 yrs
All-cause mortality
Time frame: 2yrs
Technique failure (i.e. transfer to hemodialysis)
Time frame: 2yrs
Mupirocin or Polysporin Triple resistance
Time frame: 2yrs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2015.
- Results publication: PubMed 22134627McQuillan 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.
- Derived from this study: PubMed 18178950Jassal 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.
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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.
Vanita Jassal, MD principal investigator
University Health Network, Toronto
2 sites 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 and Polysporin Triple in people with End Stage Renal Disease, run by University Health Network, Toronto at 2 sites in Canada.
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 7 inclusion and 4 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 18 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary endpoint is the time to first catheter related infection. (time frame: 2Yrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00400595, which also lists 2 linked publications.
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 18 Mar 2015.