UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034437 |
|---|---|
| Receipt number | R000039267 |
| Scientific Title | Topical mupirocin or gentamicin cream at the exit site for prevention of peritoneal dialysis catheter-related infections and withdrawal from peritoneal dialysis. |
| Date of disclosure of the study information | 2018/10/15 |
| Last modified on | 2018/10/10 14:44:31 |
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Basic information
Public title
Topical mupirocin or gentamicin cream at the exit site for prevention of peritoneal dialysis catheter-related infections and withdrawal from peritoneal dialysis.
Acronym
Topical antibiotics cream at the exit site of peritoneal dialysis patients.
Scientific Title
Topical mupirocin or gentamicin cream at the exit site for prevention of peritoneal dialysis catheter-related infections and withdrawal from peritoneal dialysis.
Scientific Title:Acronym
Topical antibiotics cream at the exit site of peritoneal dialysis patients.
Region
| Japan |
Condition
Condition
End-stage renal disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Topical antibiotics cream at the exit site for prevention of peritoneal dialysis catheter-related infections
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Peritonitis
Key secondary outcomes
Exit site infection
Technical failure
Adverse event
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Peritoneal dialysis patients
Key exclusion criteria
Recent use of antibiotics
Under 18 years of age
active infection
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naohiro Toda |
Organization
Kansai Electric Power Hospital
Division name
Division of Nephrology
Zip code
Address
2-1-7,Fukushima.Fukushima-ku. Osaka.553-0003. Japan
TEL
+81-6-6458-5821
natoda@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naohiro Toda |
Organization
Kansai Electric Power Hospital
Division name
Division of Nephrology
Zip code
Address
2-1-7,Fukushima.Fukushima-ku. Osaka.553-0003. Japan
TEL
+81-6-6458-5821
Homepage URL
natoda@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
The Japanese Society of dialysis and therapy
Institute
Department
Personal name
Funding Source
Organization
The Japanese Society of dialysis and therapy
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a systematic review on whether application of mupirocin ointment to exit site is effective in preventing exit site infection, peritonitis, or technical failure among patients treated with peritoneal dialysis (PD). It was also examined whether the application of mupirocin ointment is superior to application of gentamycin ointment to exit site in preventing exit site infection, peritonitis, or technical failure. This review is reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines
Management information
Registered date
| 2018 | Year | 10 | Month | 10 | Day |
Last modified on
| 2018 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039267
