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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001806
Receipt No. R000002147
Scientific Title Without antibiotic prophylaxis in children with mild vesicoureteral reflux (grade 0-2) after a first urinary tract infection. : A multicenter trial.
Date of disclosure of the study information 2009/03/27
Last modified on 2014/09/27

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Basic information
Public title Without antibiotic prophylaxis in children with mild vesicoureteral reflux (grade 0-2) after a first urinary tract infection. : A multicenter trial.
Acronym Without antibiotic prophylaxis in children with mild vesicoureteral reflux after a first urinary tract infection.
Scientific Title Without antibiotic prophylaxis in children with mild vesicoureteral reflux (grade 0-2) after a first urinary tract infection. : A multicenter trial.
Scientific Title:Acronym Without antibiotic prophylaxis in children with mild vesicoureteral reflux after a first urinary tract infection.
Region
Japan

Condition
Condition Urinary tract infection
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluate the clinical course of the children after a first urinary tract infection without antibiotic prophylaxis to discuss the effectiveness of continuous antibiotic prophylaxis for children with mild vesicoureteral reflux.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Relapse free survival of upper urinary tract infection.
Key secondary outcomes Relapse free survival of asymptomatic bacteriuria or cystitis.
Incidence of renal scars with DMSA renal scintigraphy.
Rate of non recurrence of upper urinary tract infection.
Development rate of renal dysfunction.

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 Treatment
Type of intervention
Medicine
Interventions/Control_1 Non-administration of antibiotics.
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
1 months-old <=
Age-upper limit
48 months-old >
Gender Male and Female
Key inclusion criteria 1) Diagnosed first episode of UTI 8 weeks before registration.
First episode of UTI
1. Body temperature >= 38.0 degrees C.
2. Positive results of urine culture by single strain (>= 10000 CFU/ml by bladder catheterization or >= 1000 CFU/ml by bladder aspiration).
2) The presence of VUR grade 0-2, monolateral or bilateral, diagnosed 2 weeks before registration.
3) Ages at the time of diagnosis of UTI are 1 months to < 4 years.
4) Written informed consent from the patients' parents or legal guardians.
Key exclusion criteria 1) Gestational age < 37 weeks.
2) Weight at birth < 2000g.
3) Complex urologic malformations.
4) Neurogenic bladder.
5) Hydronephrosis or ureteral dilation over grade 3 according to SFU classification.
6) Phimosis and ballooning at urination.
7) Previous episode of UTI.

8) Using antibiotic prophylaxis for another infection.
9) Renal dysfunction at recovery phase of UTI. (By EIA method, <1year old: sCr >= 0.4, >=1year old: sCr >= 0.5)
10) Hypertension at recovery phase of UTI.
11) Liver dysfunction at recovery phase of UTI. (AST or ALT exceed over 2.5 times the upper limit of normal).
12) Known to be immunocompromised status.
13) Intractable UTI (duration of fever >= 7days after beginning of antibiotics).
14) Complicated septic shock or DIC.
15) Judged inappropriate for this study by the physician.
Target sample size 130

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Riku Hamada
Organization Tokyo Metropolitan Children's Medical Center
Division name Department of nephrology
Zip code
Address 2-8-29 Musashidai, Fuchu-shi, TOKYO, JAPAN
TEL 042-300-5111
Email riku_hamada@tmhp.jp

Public contact
Name of contact person
1st name
Middle name
Last name Riku Hamada
Organization Tokyo Metropolitan Children's Medical Center
Division name Deparment of nephrology
Zip code
Address 2-8-29 Musashidai Fuchu-shi Tokyo
TEL 042-300-5111
Homepage URL
Email riku_hamada@tmhp.jp

Sponsor
Institute Tokyo Metropolitan Children's Medical Center
Institute
Department

Funding Source
Organization Clinical research of Tokyo metropolitan hospital group
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization Japan

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 東京都立小児総合医療センター(東京都) Tokyo Metropolitan Children's medical center

Other administrative information
Date of disclosure of the study information
2009 Year 03 Month 27 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
2008 Year 10 Month 20 Day
Date of IRB
Anticipated trial start date
2008 Year 12 Month 01 Day
Last follow-up date
2015 Year 08 Month 31 Day
Date of closure to data entry
2015 Year 12 Month 01 Day
Date trial data considered complete
2015 Year 12 Month 01 Day
Date analysis concluded
2015 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 03 Month 27 Day
Last modified on
2014 Year 09 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002147

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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