Topical Gentamicin Cream Versus Alternating Gentamicin and Mupirocin Cream in Peritoneal Dialysis - Full Text View

Sponsor:	Kwong Wah Hospital
Collaborator:	Hong Kong Society of Nephrology
Information provided by:	Kwong Wah Hospital
ClinicalTrials.gov Identifier:	NCT00751374

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 IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Antibiotics Kidney Failure Mycobacterial Infections

Drug Information available for: Mupirocin Mupirocin calcium Gentamicins

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
Group B: Active Comparator 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

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:

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

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
Hong Kong, Hong Kong

Sponsors and Collaborators

Kwong Wah Hospital

Hong Kong Society of Nephrology

Investigators

Principal Investigator:

Gensy MW Tong, MBChB

Kwong Wah Hospital

More Information

No publications provided

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

Additional relevant MeSH terms:

Bacterial Infections
Communicable Diseases
Anti-Infective Agents
Mupirocin
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection
Mycobacterium Infections, Atypical

Actinomycetales Infections
Pharmacologic Actions
Protein Synthesis Inhibitors
Anti-Bacterial Agents
Gram-Positive Bacterial Infections
Therapeutic Uses
Gentamicins
Mycobacterium Infections

ClinicalTrials.gov processed this record on February 08, 2010