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

NCT00751374 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2008-09-11

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • The Hong Kong Society of Nephrology

    collaborator OTHER

  • Kwong Wah Hospital

    lead OTHER

Principal Investigators

  • Gensy MW Tong, MBChB · Kwong Wah Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00751374 on ClinicalTrials.gov