UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038500 |
|---|---|
| Receipt number | 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 | 2023/04/09 00:34:23 |
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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
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
h.shima@khg.or.jp
Sponsor or person
Institute
Kawashima hospital
Institute
Department
Personal name
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
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
Completed
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
| 2023 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043873
