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

Rate of Atypical Mycobacterial Infection Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00751374
• Other study ID #: KW/FR/08-007
• Status: Not yet recruiting
• Phase: Phase 4
• First received: September 10, 2008
• Last updated: September 10, 2008
• Start date: September 2008
• Est. completion date: October 2014

Study information

• Verified date: September 2008
• Source: Kwong Wah Hospital
• Contact: Gensy MW Tong, MBChB
• Phone: 852-3517-5000
• Email: gensytong[@]hotmail.com
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infection
• Mycobacterium Infections
• Mycobacterium Infections, Nontuberculous
• Rate of Atypical Mycobacterial Infection
• Rate of Exit Site Infection
• Rate of Peritoneal Dialysis

Intervention

Drug:
• gentamicin
topical gentamicin cream on daily basis
• gentamicin cream alternating with mupirocin cream
topical gentamicin cream alternating with mupirocin cream at monthly basis

Locations

Country	Name	City	State
Hong Kong	Kwong Wah Hospital	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
Kwong Wah Hospital	The Hong Kong Society of Nephrology

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Exit site infection		every 3 months	Yes
Secondary	Rate of peritonitis		every 3 months	Yes