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

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.

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.

Study Overview

• Status: Unknown
• Conditions: Rate of Exit Site Infection; Rate of Atypical Mycobacterial Infection; Rate of Peritoneal Dialysis
• Intervention / Treatment: Drug: gentamicin; Drug: gentamicin cream alternating with mupirocin cream

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.

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Phase 4

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Kwong Wah Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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 Names: Gentamicin and mupirocin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of Exit site infection	every 3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Rate of peritonitis	every 3 months

Collaborators and Investigators

• Sponsor: Kwong Wah Hospital
• Collaborators: The Hong Kong Society of Nephrology
• Investigators: Principal Investigator: Gensy MW Tong, MBChB, Kwong Wah Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Anticipated): October 1, 2014
• Study Completion (Anticipated): October 1, 2014

Study Registration Dates

• First Submitted: September 10, 2008
• First Submitted That Met QC Criteria: September 10, 2008
• First Posted (Estimate): September 11, 2008

Study Record Updates

• Last Update Posted (Estimate): September 11, 2008
• Last Update Submitted That Met QC Criteria: September 10, 2008
• Last Verified: September 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Infections; Communicable Diseases; Mycobacterium Infections; Mycobacterium Infections, Nontuberculous; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Mupirocin; Gentamicins
• Other Study ID Numbers: KW/FR/08-007