UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037391 |
|---|---|
| Receipt number | R000042557 |
| Scientific Title | Prophylactic Antibiotics for Post-endoscopic Peritonitis in Peritoneal Dialysis |
| Date of disclosure of the study information | 2019/07/17 |
| Last modified on | 2019/07/16 22:32:12 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Prophylactic Antibiotics for Post-endoscopic Peritonitis in Peritoneal Dialysis
Acronym
Post-endoscopic Peritonitis
Scientific Title
Prophylactic Antibiotics for Post-endoscopic Peritonitis in Peritoneal Dialysis
Scientific Title:Acronym
Post-endoscopic Peritonitis
Region
| Japan |
Condition
Condition
peritoneal dialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the association between prophylactic oral antibiotic administration and GIE-associated peritonitis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
GIE-associated peritonitis
Key secondary outcomes
Base
Study type
Observational
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who received PD treatment in our hospital from April 2008 to March 2018
Key exclusion criteria
Patients who received therapeutic antibiotics for exit-site or other infections
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Oka |
Organization
Matsuyama red cross hospital
Division name
Nephrology
Zip code
790-0833
Address
1 Bunkyo-cho, Matsuyama City, Ehime
TEL
089-924-1111
okanokao@matsuyama.jrc.or.jp
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | Oka |
Organization
Matsuyama red cross hospital
Division name
Nephrology
Zip code
790-0833
Address
1 Bunkyo-cho, Matsuyama City, Ehime
TEL
089-924-1111
Homepage URL
okanokao@matsuyama.jrc.or.jp
Sponsor or person
Institute
Matsuyama red cross hospital
Institute
Department
Personal name
Funding Source
Organization
Matsuyama red cross 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
Matsuyama red cross hospital
Address
1 Bunkyo-cho, Matsuyama City, Ehime
Tel
089-924-1111
okanokao@matsuyama.jrc.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 | 07 | Month | 17 | 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
91
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Now preparing for submission
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 | 06 | Month | 04 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 04 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 04 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We retrospectively reviewed the association between prophylactic oral antibiotic administration and PD-related peritonitis occurring by the day after gastrointestinal endoscopy in 140 patients who received PD treatment in our hospital from April 2008 to March 2018.
Management information
Registered date
| 2019 | Year | 07 | Month | 16 | Day |
Last modified on
| 2019 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042557
