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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00751374
Recruitment Status : Unknown
Verified September 2008 by Kwong Wah Hospital.
Recruitment status was:  Not yet recruiting
First Posted : September 11, 2008
Last Update Posted : September 11, 2008
The Hong Kong Society of Nephrology
Information provided by:
Kwong Wah Hospital

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.

Condition or disease Intervention/treatment 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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : September 2008
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
group A
Topical gentamicin cream
Drug: gentamicin
topical gentamicin cream on daily basis

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

Primary Outcome Measures :
  1. Rate of Exit site infection [ Time Frame: every 3 months ]

Secondary Outcome Measures :
  1. Rate of peritonitis [ Time Frame: every 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00751374

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Contact: Gensy MW Tong, MBChB 852-3517-5000

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Hong Kong
Kwong Wah Hospital
Hong Kong, Hong Kong
Contact: Gensy MW Tong, MBChB    852-3517-5000   
Sponsors and Collaborators
Kwong Wah Hospital
The Hong Kong Society of Nephrology
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Principal Investigator: Gensy MW Tong, MBChB Kwong Wah Hospital
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Responsible Party: Tong Mei Wa Gensy, Kwong Wah Hospital Identifier: NCT00751374    
Other Study ID Numbers: KW/FR/08-007
First Posted: September 11, 2008    Key Record Dates
Last Update Posted: September 11, 2008
Last Verified: September 2008
Additional relevant MeSH terms:
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Communicable Diseases
Mycobacterium Infections
Mycobacterium Infections, Nontuberculous
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action