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

NCT ID: NCT00751374

Last Updated: 2008-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2014-10-31

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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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group A

Topical gentamicin cream

Group Type OTHER

gentamicin

Intervention Type DRUG

topical gentamicin cream on daily basis

Group B

topical gentamicin cream alternates with mupirocin cream at monthly basis

Group Type ACTIVE_COMPARATOR

gentamicin cream alternating with mupirocin cream

Intervention Type DRUG

topical gentamicin cream alternating with mupirocin cream at monthly basis

Interventions

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gentamicin

topical gentamicin cream on daily basis

Intervention Type DRUG

gentamicin cream alternating with mupirocin cream

topical gentamicin cream alternating with mupirocin cream at monthly basis

Intervention Type DRUG

Other Intervention Names

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Gentamicin and mupirocin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hong Kong Society of Nephrology

OTHER

Sponsor Role collaborator

Kwong Wah Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kwong Wah Hospital

Principal Investigators

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Gensy MW Tong, MBChB

Role: PRINCIPAL_INVESTIGATOR

Kwong Wah Hospital

Locations

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Kwong Wah Hospital

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

Central Contacts

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Gensy MW Tong, MBChB

Role: CONTACT

Phone: 852-3517-5000

Email: [email protected]

Facility Contacts

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Gensy MW Tong, MBChB

Role: primary

Other Identifiers

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KW/FR/08-007

Identifier Type: -

Identifier Source: org_study_id