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

NCT00751374 | Unknown Phase 4 DMC

• 1 other identifier: KW/FR/08-007
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Rate of Exit site infection

  every 3 months

Secondary Outcomes (1)

• Rate of peritonitis

  every 3 months

Study Arms (2)

group A

OTHER

Topical gentamicin cream

Drug: gentamicin

Group B

ACTIVE COMPARATOR

topical gentamicin cream alternates with mupirocin cream at monthly basis

Drug: gentamicin cream alternating with mupirocin cream

Interventions

gentamicin DRUG

topical gentamicin cream on daily basis

group A

gentamicin cream alternating with mupirocin cream DRUG

topical gentamicin cream alternating with mupirocin cream at monthly basis

Also known as: Gentamicin and mupirocin

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kwong Wah Hospital: lead
• The Hong Kong Society of Nephrology: collaborator

Study Sites (1)

Kwong Wah Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Interventions

Gentamicins; Mupirocin

Intervention Hierarchy (Ancestors)

Aminoglycosides; Glycosides; Carbohydrates; Epoxy Compounds; Ethers, Cyclic; Ethers; Organic Chemicals; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fatty Acids; Lipids

Study Officials

• Gensy MW Tong, MBChB

  Kwong Wah Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gensy MW Tong, MBChB

CONTACT

852-3517-5000; gensytong@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 10, 2008
• First Posted: September 11, 2008
• Study Start: September 1, 2008
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: September 11, 2008

Record last verified: 2008-09

Locations

HK (1)