Topical Gentamicin Cream Versus Alternating Gentamicin and Mupirocin Cream in Peritoneal Dialysis
Information source: Kwong Wah Hospital
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rate of Exit Site Infection; Rate of Atypical Mycobacterial Infection; Rate of Peritoneal Dialysis
Intervention: gentamicin (Drug); gentamicin cream alternating with mupirocin cream (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Kwong Wah Hospital Official(s) and/or principal investigator(s):
Gensy MW Tong, MBChB, Principal Investigator, Affiliation: Kwong Wah Hospital
Overall contact:
Gensy MW Tong, MBChB, Phone: 852-3517-5000, Email: gensytong@hotmail.com
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.
Clinical Details
Official title: 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.
Study design: Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Rate of Exit site infection
Secondary outcome: Rate of peritonitis
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Patient aged 18 years old or above
2. Patient has Tenckhoff catheter inserted
3. Patient is expected to continue his or her dialysis in our center in the subsequent 3
years
Exclusion Criteria:
1. Patient fails to sign the written consent
2. Patient known to have allergy to either gentamicin or mupirocin
3. Patient has suffered from peritonitis or exit site infection 30 days before the
enrollment.
4. Patient, suffering from terminal illness, has life-expectancy of less than one year
5. 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.
6. Pregnant patient
7. Patient known to be non-compliant
8. Patient bound by another clinical study
Locations and Contacts
Gensy MW Tong, MBChB, Phone: 852-3517-5000, Email: gensytong@hotmail.com
Kwong Wah Hospital, Hong Kong, Hong Kong
Additional Information
Starting date: September 2008
Ending date: October 2014
Last updated: September 10, 2008
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