UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013848 |
|---|---|
| Receipt number | R000016106 |
| Scientific Title | PcrV of Pseudomonas aeruginosa in patients with gastrointestinal perforation |
| Date of disclosure of the study information | 2014/06/01 |
| Last modified on | 2016/05/06 10:56:43 |
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Basic information
Public title
PcrV of Pseudomonas aeruginosa in patients with gastrointestinal perforation
Acronym
PcrV of Pseudomonas aeruginosa in patients with gastrointestinal perforation
Scientific Title
PcrV of Pseudomonas aeruginosa in patients with gastrointestinal perforation
Scientific Title:Acronym
PcrV of Pseudomonas aeruginosa in patients with gastrointestinal perforation
Region
| Japan |
Condition
Condition
patients with gastrointestinal perforation
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Patients with gastrointestinal perforation will be evaluated for increases in titers against PcrV of Pseudomonas aeruginosa while staying in the intensive care unit following surgery
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Recording titers against PcrV
Key secondary outcomes
genomic analysis of Pseudomonas aeruginosa
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
| 10 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with gastrointestinal perforation
Key exclusion criteria
no
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyoshi Moriyama |
Organization
School of medicine, Kyorin University
Division name
Department of anesthesiology,
Zip code
Address
6-20-2 Shinkawa, Mitaka-shi, Tokyo
TEL
0422-47-5511
mokiyo@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kiyoshi Moriyama |
Organization
School of medicine, Kyorin University
Division name
Department of anesthesiology,
Zip code
Address
6-20-2 Shinkawa, Mitaka-shi, Tokyo
TEL
0422-47-5511
Homepage URL
mokiyo@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Department of anesthesiology, School of medicine, Kyorin University
Institute
Department
Personal name
Funding Source
Organization
School of medicine, Kyorin University
Organization
Division
Category of Funding Organization
Other
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
| 2014 | Year | 06 | Month | 01 | 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
| 2014 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 05 | Month | 31 | Day |
Other
Other related information
an observational study
Management information
Registered date
| 2014 | Year | 04 | Month | 30 | Day |
Last modified on
| 2016 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016106
