NCT00751374

Topical Gentamicin Cream Versus Alternating Gentamicin and Mupirocin Cream in Peritoneal Dialysis

Prospective, Randomized, Open-Label Study of Topical Antibiotic Prophylaxis at the Catheter Exit Site: Continuous Daily Gentamicin Cream Versus Cyclical Gentamicin Cream and Mupirocin 2% Cream Alternating at Monthly Basis.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Kwong Wah Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Rate of Exit Site Infection
• Rate of Atypical Mycobacterial Infection
• Rate of Peritoneal Dialysis

Interventions

Type	Name	Description
DRUG	gentamicin	topical gentamicin cream on daily basis
DRUG	gentamicin cream alternating with mupirocin cream	topical gentamicin cream alternating with mupirocin cream at monthly basis

Timeline

• Start date: 2008-09-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2008-09-11
• Last updated: 2008-09-11

Locations

1 site across 1 country: Hong Kong