Rate of Exit Site InfectionPhase 4NCT00751374
Topical Gentamicin Cream Versus Alternating Gentamicin and Mupirocin Cream in Peritoneal Dialysis
A Phase 4 study testing gentamicin and gentamicin cream alternating with mupirocin cream in people with Rate of Exit Site Infection and Rate of Atypical Mycobacterial Infection, run by Kwong Wah Hospital at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rate of Exit Site Infection, Rate of Atypical Mycobacterial Infection, Rate of Peritoneal Dialysis
- What is being tested?
- gentamicin and gentamicin cream alternating with mupirocin cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteHong Kong
- Study dates
- Sep 2008to Oct 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Kwong Wah Hospital
Hong Kong
Gensy MW Tong, MBChB, 852-3517-5000, gensytong@hotmail.com
About this 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.
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.
Read the 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.
- Conditions
- Rate of Exit Site Infection, Rate of Atypical Mycobacterial Infection, Rate of Peritoneal Dialysis
- Being tested
- gentamicin, gentamicin cream alternating with mupirocin cream
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gentamicinDrug
topical gentamicin cream on daily basis
gentamicin cream alternating with mupirocin creamDrug
Also called Gentamicin and mupirocin
topical gentamicin cream alternating with mupirocin cream at monthly basis
| Study group | Role | What they receive |
|---|---|---|
| group A | Other | Topical gentamicin cream Receives: Drug: gentamicin |
| Group B | Active comparator | topical gentamicin cream alternates with mupirocin cream at monthly basis Receives: Drug: gentamicin cream alternating with mupirocin cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Exit site infection
Measured: every 3 months
Secondary outcomes (1)
Rate of peritonitis
Measured: every 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionOct 2014 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rate of Exit Site InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kwong Wah Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Hong Kong Society of Nephrology
- Investigators
- Gensy MW Tong, MBChB, Principal investigator, Kwong Wah Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00751374
- Sponsor's protocol ID
- KW/FR/08-007
- Status last verified
- Sep 2008
- First submitted
- 10 Sep 2008
- Last updated
- 11 Sep 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00751374
- Acronym / sponsor ID
- KW/FR/08-007
- Conditions
- Rate of Exit Site Infection, Rate of Atypical Mycobacterial Infection, Rate of Peritoneal Dialysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Kwong Wah HospitalUniversity, hospital or other
- Collaborators
- The Hong Kong Society of Nephrology
- Study start
- Sep 2008
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 11 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Other | Drug: gentamicinTopical gentamicin cream |
| Group B | Active comparator | Drug: gentamicin cream alternating with mupirocin creamtopical gentamicin cream alternates with mupirocin cream at monthly basis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gentamicintopical gentamicin cream on daily basis | Drug | group A |
| gentamicin cream alternating with mupirocin creamAlso: Gentamicin and mupirocintopical gentamicin cream alternating with mupirocin cream at monthly basis | Drug | Group B |
Primary outcome
Rate of Exit site infection
Time frame: every 3 months
1 secondary outcome
Rate of peritonitis
Time frame: every 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2008.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gensy MW Tong, MBChB principal investigator
Kwong Wah Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing gentamicin and gentamicin cream alternating with mupirocin cream in people with Rate of Exit Site Infection and Rate of Atypical Mycobacterial Infection, run by Kwong Wah Hospital at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gensy MW Tong, MBChB (852-3517-5000, gensytong@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Exit site infection (time frame: every 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2008.