UMIN-CTR Clinical Trial

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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