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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00751374

Enrollment

500

Registered

2008-09-11

Start date

2008-09-30

Completion date

2014-10-31

Last updated

2008-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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.

Interventions

DRUGgentamicin

topical gentamicin cream on daily basis

DRUGgentamicin cream alternating with mupirocin cream

topical gentamicin cream alternating with mupirocin cream at monthly basis

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Rate of Exit site infection	every 3 months

Secondary

Measure	Time frame
Rate of peritonitis	every 3 months

Countries

Hong Kong

Contacts

Primary ContactGensy MW Tong, MBChB

gensytong@hotmail.com852-3517-5000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026