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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Rate of Exit Site Infection, Rate of Atypical Mycobacterial Infection, Rate of Peritoneal Dialysis

Intervention / Treatment
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* Drug: gentamicin
* Drug: gentamicin cream alternating with mupirocin cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient aged 18 years old or above Patient has Tenckhoff catheter inserted Patient is expected to continue his or her dialysis in our center in the subsequent 3 years Exclusion Criteria: Patient fails to sign the written consent Patient known to have allergy to either gentamicin or mupirocin Patient has suffered from peritonitis or exit site infection 30 days before the enrollment. Patient, suffering from terminal illness, has life-expectancy of less than one year Patient expected to undergo peritoneal dialysis for less than one year, such as patients planning for elective renal transplantation or suffering from acute renal failure necessitating dialysis while waiting for the kidney to recover. Pregnant patient Patient known to be non-compliant Patient bound by another clinical study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: group A<br>Topical gentamicin cream | Drug: gentamicin<br>* topical gentamicin cream on daily basis<br>|
| Active Comparator: Group B<br>topical gentamicin cream alternates with mupirocin cream at monthly basis | Drug: gentamicin cream alternating with mupirocin cream<br>* topical gentamicin cream alternating with mupirocin cream at monthly basis<br>* Other names: Gentamicin and mupirocin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Exit site infection |  | every 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of peritonitis |  | every 3 months |