UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008860 |
|---|---|
| Receipt number | R000010403 |
| Scientific Title | Evaluation of 99mTc-DMSA static renal scintigraphy in acute period of first upper urinary tract infection. |
| Date of disclosure of the study information | 2012/09/06 |
| Last modified on | 2012/09/05 18:51:10 |
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Basic information
Public title
Evaluation of 99mTc-DMSA static renal scintigraphy in acute period of first upper urinary tract infection.
Acronym
99mTc-DMSA scintigraphy in acute period upper UTI.
Scientific Title
Evaluation of 99mTc-DMSA static renal scintigraphy in acute period of first upper urinary tract infection.
Scientific Title:Acronym
99mTc-DMSA scintigraphy in acute period upper UTI.
Region
| Japan |
Condition
Condition
Upper urinary tract infection
(Acute pyelonephritis, Acute focal bacterial nephronia)
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify whether the relapse of urinary tract infection is not made to increase when it do not carry out voiding cystourethrography and chemical prophylaxis to the case who does not show a loss of accumulation in 99mTc-DMSA static renal scintigraphy in acute period of first upper urinary infection.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
relapse of upper urinary tract infection
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
99 mTc-DMSA stastic renal scintigraphy is performed at a first-time upper urinary tract infection acute period, and voiding cystourethrography and chemical prophylaxis are not carried out to the case which does not show a loss of accumulation.
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
| 0 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Who fills following all;
1)fever(38.0 degrees Celsius or higher)
2)White blood cells positive in urine inspection, or more than 10/field of white blood cells in urinary resident.
3)10^4 CFU/mcl(or more)of bacteria in semiquantitive urinary culture.
Key exclusion criteria
Who fills following either;
1)Relapsed Urinary tract infection
2)Who shows the apparent hydronephrosis or space occupied lesion by an abdomen ultrasound test
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuaki Abe |
Organization
Chiba Kaihin Municipal Hospital
Division name
Pediatrics
Zip code
Address
Isobe 3-31-1, Chiba city, Chiba prefecture, Japan.
TEL
043-277-7711
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Chiba Kaihin Municipal Hospital
Division name
Pediatrics
Zip code
Address
Isobe 3-31-1, Chiba city, Chiba prefecture, Japan.
TEL
Homepage URL
Sponsor or person
Institute
Chiba Kaihin Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
Chiba Kaihin Municipal 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
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
| 2012 | Year | 09 | Month | 06 | 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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2012 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2012 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 09 | Month | 05 | Day |
Last modified on
| 2012 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010403
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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