Catheter-related infection, namely exit site infection and peritonitis, is the commonest complication of peritoneal dialysis. This complication causes significant morbidity and mortality in patients requiring peritoneal dialysis. Topical application of mupirocin 2% cream was first proven to be effective in reduction of staphylococcus-related catheter infection in 1990s. Subsequent randomized trial published in 2005 showed that gentamicin cream was superior to mupirocin 2% cream in reducing both Gram's positive and Gram's negative related catheter infection. However, a retrospective report published in 2007 puts the use of prophylactic antibiotic cream into a question. It reported an emergency of non-tuberculous mycobacterial infection in a dialysis center in Hong Kong after practising prophylactic application of gentamicin cream at the catheter exit site. The following prospective, randomized and open-label study aims to find out an optimal regimen of topical antibiotic prophylaxis in patients requiring peritoneal dialysis.
Primary Outcome Measures:
- Rate of Exit site infection [ Time Frame: every 3 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Rate of peritonitis [ Time Frame: every 3 months ] [ Designated as safety issue: Yes ]
Estimated Enrollment: |
500 |
Study Start Date: |
September 2008 |
Estimated Study Completion Date: |
October 2014 |
Estimated Primary Completion Date: |
October 2014 (Final data collection date for primary outcome measure) |
group A
Topical gentamicin cream
|
Drug: gentamicin
topical gentamicin cream on daily basis
|
Group B: Active Comparator
topical gentamicin cream alternates with mupirocin cream at monthly basis
|
Drug: gentamicin cream alternating with mupirocin cream
topical gentamicin cream alternating with mupirocin cream at monthly basis
|
Topical antibiotics therapy is a well-recognized prophylactic therapy towards the catheter exit site infection in peritoneal dialysis patient. Previous data has shown the superiority of gentamicin cream over the mupirocin cream in this aspect. However, the efficacy of the combination therapy using gentamicin cream alternating with mupirocin cream has not been tested. There is a potention benefit of reducing drug resistant strain in the combination group theoretically.