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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000038500
Receipt No. R000043873
Scientific Title Investigation of methods for preventing biofilm formation in peritoneal dialysis-related peritonitis
Date of disclosure of the study information 2019/11/11
Last modified on 2019/11/06

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Basic information
Public title Investigation of methods for preventing biofilm formation in peritoneal dialysis-related peritonitis
Acronym Investigation of methods for preventing biofilm formation in peritoneal dialysis-related peritonitis
Scientific Title Investigation of methods for preventing biofilm formation in peritoneal dialysis-related peritonitis
Scientific Title:Acronym Investigation of methods for preventing biofilm formation in peritoneal dialysis-related peritonitis
Region
Japan

Condition
Condition End stage renal disease, Peritoneal dialysis-related peritonitis
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to investigate the effect of clarithromycin for preventing the biofilm formation in patients with peritoneal dialysis-related peritonitis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Peritonitis relapse rates, peritoneal dialysis catheter removal rates
Key secondary outcomes Age, gender, weight, dialysis vintage, complications (diabetes, hypertension, heart disease), clinical symptoms at the time of peritonitis diagnosis (fever, abdominal pain, drainage turbidity, diarrhea), white blood cell counts in dialysis drainage at the time of peritonitis diagnosis, percentage of multinucleated leukocytes, blood tests at the time of peritonitis diagnosis (white blood cell count, neutrophil count, hemoglobin, albumin, CRP, etc.), causative bacteria, number of drained cells under treatment, peritonitis recurrence rate

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Clarithromycin treatment group:
Clarithromycin 100 mg/day, po (at least 14 days), cefazolin sodium 1 g/day, iv, and isepamicin sulfate 0.1g/day (0.2g, 1st day), iv (at least 14 days)
Interventions/Control_2 Standard treatment group:
cefazolin sodium 1 g/day, iv, and isepamicin sulfate 0.1g/day (0.2g, 1st day), iv (at least 14 days)
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with peritoneal dialysis treatment
Patients fulfilled at least two of the diagnosis criteria for peritoneal dialysis-related peritonitis (1. There were clinical signs of peritonitis such as abdominal pain, drainage turbidity. 2. The number of leukocytes in dialysis drainage after storage for at least two hours was more than 100/microL, and more than 50 percents of multinucleated leukocytes. 3. The result of drainage culture was positive)
Patients who have obtained consent for hospitalization treatment for more than two weeks
Key exclusion criteria Patients with a history of allergies to macrolide
Patients complicated with exit infections and tunnel infections
Patients with less than two weeks of treatment periods
Patients suspected of biofilm formation due to peritonitis more than four weeks after previous peritonitis, the pathogenic microorganism is the same as previous one, or bacteria could not be detected.
Patients without agreement on enrolment of this study
Inappropriate patients judged by doctor
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Hisato
Middle name
Last name Shima
Organization Kawashima hospital
Division name Department of Kidney Disease
Zip code 770-0011
Address 1-39 Kitasakoichiban-cho, Tokushima city 770-0011, Tokushima, Japan
TEL 088-631-0110
Email h.shima@khg.or.jp

Public contact
Name of contact person
1st name Hisato
Middle name
Last name Shima
Organization Kawashima hospital
Division name Department of Kidney Disease
Zip code 770-0011
Address 1-39 Kitasakoichiban-cho, Tokushima city 770-0011, Tokushima, Japan
TEL 088-631-0110
Homepage URL
Email h.shima@khg.or.jp

Sponsor
Institute Kawashima hospital
Institute
Department

Funding Source
Organization Kawashima hospital
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 Kawashima hospital
Address 1-39 Kitasakoichiban-cho, Tokushima city 770-0011, Tokushima, Japan
Tel 088-631-0110
Email h.shima@khg.or.jp

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
2019 Year 11 Month 11 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Enrolling by invitation
Date of protocol fixation
2019 Year 11 Month 01 Day
Date of IRB
2019 Year 11 Month 05 Day
Anticipated trial start date
2019 Year 11 Month 11 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 11 Month 06 Day
Last modified on
2019 Year 11 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043873

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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