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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000008860
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Chiba Kaihin Municipal Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010403

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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