UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Topical mupirocin or gentamicin cream at the exit site for prevention of peritoneal dialysis catheter-related infections and withdrawal from peritoneal dialysis.
Title of the study (Brief title)	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	Naohiro Toda
Organization	Kansai Electric Power Hospital
Division name	Division of Nephrology
Address	2-1-7,Fukushima.Fukushima-ku. Osaka.553-0003. Japan
TEL	+81-6-6458-5821
Email	natoda@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Naohiro Toda
Organization	Kansai Electric Power Hospital
Division name	Division of Nephrology
Address	2-1-7,Fukushima.Fukushima-ku. Osaka.553-0003. Japan
TEL	+81-6-6458-5821
Homepage URL
Email	natoda@kuhp.kyoto-u.ac.jp

Sponsor
Institute	The Japanese Society of dialysis and therapy
Institute
Department

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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2017 Year 03 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039267