![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
Sponsors and Collaborators: |
Kwong Wah Hospital Hong Kong Society of Nephrology |
---|---|
Information provided by: | Kwong Wah Hospital |
ClinicalTrials.gov Identifier: | NCT00751374 |
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. |
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
|
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Gensy MW Tong, MBChB | 852-3517-5000 | gensytong@hotmail.com |
Hong Kong | |
Kwong Wah Hospital | |
Hong Kong, Hong Kong |
Principal Investigator: | Gensy MW Tong, MBChB | Kwong Wah Hospital |
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 |
Health Authority: | Hong Kong: Ethics Committee |
Bacterial Infections Gram-Positive Bacterial Infections Mupirocin |
Gentamicins Mycobacterium Infections Mycobacterium Infections, Atypical |
Protein Synthesis Inhibitors Anti-Infective Agents Anti-Bacterial Agents Communicable Diseases Molecular Mechanisms of Pharmacological Action |
Therapeutic Uses Enzyme Inhibitors Infection Pharmacologic Actions Actinomycetales Infections |