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

Primary Purpose

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

Status
Unknown status
Phase
Phase 4
Locations
Hong Kong
Study Type
Interventional
Intervention
gentamicin
gentamicin cream alternating with mupirocin cream
Sponsored by
Kwong Wah Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rate of Exit Site Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Kwong Wah Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

group A

Group B

Arm Description

Topical gentamicin cream

topical gentamicin cream alternates with mupirocin cream at monthly basis

Outcomes

Primary Outcome Measures

Rate of Exit site infection

Secondary Outcome Measures

Rate of peritonitis

Full Information

First Posted
September 10, 2008
Last Updated
September 10, 2008
Sponsor
Kwong Wah Hospital
Collaborators
The Hong Kong Society of Nephrology
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1. Study Identification

Unique Protocol Identification Number
NCT00751374
Brief Title
Topical Gentamicin Cream Versus Alternating Gentamicin and Mupirocin Cream in Peritoneal Dialysis
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 Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Unknown status
Study Start Date
September 2008 (undefined)
Primary Completion Date
October 2014 (Anticipated)
Study Completion Date
October 2014 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Kwong Wah Hospital
Collaborators
The Hong Kong Society of Nephrology

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rate of Exit Site Infection, Rate of Atypical Mycobacterial Infection, Rate of Peritoneal Dialysis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group A
Arm Type
Other
Arm Description
Topical gentamicin cream
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
topical gentamicin cream alternates with mupirocin cream at monthly basis
Intervention Type
Drug
Intervention Name(s)
gentamicin
Intervention Description
topical gentamicin cream on daily basis
Intervention Type
Drug
Intervention Name(s)
gentamicin cream alternating with mupirocin cream
Other Intervention Name(s)
Gentamicin and mupirocin
Intervention Description
topical gentamicin cream alternating with mupirocin cream at monthly basis
Primary Outcome Measure Information:
Title
Rate of Exit site infection
Time Frame
every 3 months
Secondary Outcome Measure Information:
Title
Rate of peritonitis
Time Frame
every 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gensy MW Tong, MBChB
Phone
852-3517-5000
Email
gensytong@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gensy MW Tong, MBChB
Organizational Affiliation
Kwong Wah Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kwong Wah Hospital
City
Hong Kong
Country
Hong Kong
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gensy MW Tong, MBChB
Phone
852-3517-5000
Email
gensytong@hotmail.com

12. IPD Sharing Statement

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

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