UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041899 |
|---|---|
| Receipt number | R000047824 |
| Scientific Title | Factors associated with atypical presentation in patients with bacteraemic urinary tract infection. |
| Date of disclosure of the study information | 2020/09/26 |
| Last modified on | 2023/10/14 19:36:01 |
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Basic information
Public title
Factors associated with atypical presentation in patients with bacteraemic urinary tract infection.
Acronym
Factors associated with atypical presentation in patients with bacteraemic urinary tract infection.
Scientific Title
Factors associated with atypical presentation in patients with bacteraemic urinary tract infection.
Scientific Title:Acronym
Factors associated with atypical presentation in patients with bacteraemic urinary tract infection.
Region
| Japan |
Condition
Condition
Infectious disease
Classification by specialty
| Medicine in general | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate factors associated with atypical presentation at initial contact among patients with urinary tract infection.
Basic objectives2
Others
Basic objectives -Others
The effect of atypical presentation on the correct diagnosis of UTI at initial contact will be also evaluated.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Atypical presentation defined as the absence of any urinary tract symptom or sign at initial contact
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with bacteraemic UTI that satisfy all of the followings;
(1) Fever or chills, any symptoms of cystitis, or any symptoms of pyelonephritis
(2) The same bacterial pathogen is isolated in concurrent urinary and blood cultures, and there are no other sources of infection
(3) The bacterial pathogen is present at more or 10000 CFU/ml of urine.
Key exclusion criteria
Renal abscess, proctitis, and cystitis
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Junpei |
| Middle name | |
| Last name | Komagamine |
Organization
NHO Tochigi Medical Center
Division name
Internal medicine
Zip code
3208580
Address
1-10-37, Nakatomatsuri, Utsunomiya
TEL
028-622-5241
jkomagamine@tochigi-mc.jp
Public contact
Name of contact person
| 1st name | Junpei |
| Middle name | |
| Last name | Komagamine |
Organization
NHO Tochigi Medical Center
Division name
Internal medicine
Zip code
3208580
Address
1-10-37, Nakatomatsuri, Utsunomiya
TEL
028-622-5241
Homepage URL
jkomagamine@tochigi-mc.jp
Sponsor or person
Institute
NHO Tochigi Medical Center
Institute
Department
Personal name
Funding Source
Organization
None.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Saiseikai Utsunomiya Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NHO Tochigi Medical Center
Address
1-10-37, Nakatomatsuri, Utsunomiya
Tel
028-622-5241
atamura@tochigi-mc.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
| 2020 | Year | 09 | Month | 26 | 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
285
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
Main results already published
Date of protocol fixation
| 2019 | Year | 10 | Month | 29 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A retrospective and prospective, cross-sectional study using electronic medical records will be conducted. We will determine factors associated with atypical presentation at initial contact among patients with bacteraemic UTI. The primary outcome is atypical presentation, defined as the absence of any urinary tract symptom or sign at initial contact. We will also include patients with bacteraemic UTI from September 2014 to March 2021.
Management information
Registered date
| 2020 | Year | 09 | Month | 26 | Day |
Last modified on
| 2023 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047824
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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