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Trial record 4 of 9 for:    Open Studies | "Mycobacterium Infections, Atypical"
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Topical Gentamicin Cream Versus Alternating Gentamicin and Mupirocin Cream in Peritoneal Dialysis

This study is not yet open for participant recruitment.
Verified September 2008 by Kwong Wah Hospital
Sponsor:
Collaborator:
The Hong Kong Society of Nephrology
Information provided by:
Kwong Wah Hospital
ClinicalTrials.gov Identifier:
NCT00751374
First received: September 10, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Rate of Exit Site Infection
Rate of Atypical Mycobacterial Infection
Rate of Peritoneal Dialysis
 Drug: gentamicin
Drug: gentamicin cream alternating with mupirocin cream
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kwong Wah Hospital:

Primary Outcome Measures:
  • Rate of Exit site infection [ Time Frame: every 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rate of peritonitis [ Time Frame: every 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 500
Study Start Date: September 2008
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
group A
Topical gentamicin cream
 Drug: gentamicin
topical gentamicin cream on daily basis
Other Name: Gentamicin
Active Comparator: Group B
topical gentamicin cream alternates with mupirocin cream at monthly basis
 Drug: gentamicin cream alternating with mupirocin cream
topical gentamicin cream alternating with mupirocin cream at monthly basis
Other Name: Gentamicin and mupirocin

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00751374

Contacts
Contact: Gensy MW Tong, MBChB 852-3517-5000 gensytong@hotmail.com

Locations
Hong Kong
Kwong Wah Hospital Not yet recruiting
Hong Kong, Hong Kong
Contact: Gensy MW Tong, MBChB     852-3517-5000     gensytong@hotmail.com    
Sponsors and Collaborators
Kwong Wah Hospital
The Hong Kong Society of Nephrology
Investigators
Principal Investigator: Gensy MW Tong, MBChB Kwong Wah Hospital
  More Information

No publications provided

Responsible Party: Tong Mei Wa Gensy, Kwong Wah Hospital
ClinicalTrials.gov Identifier: NCT00751374     History of Changes
Other Study ID Numbers: KW/FR/08-007
Study First Received: September 10, 2008
Last Updated: September 10, 2008
Health Authority: Hong Kong: Ethics Committee

Additional relevant MeSH terms:
Mycobacterium Infections, Atypical
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Gentamicins
Mupirocin
 Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013