UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001806 |
|---|---|
| Receipt number | 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 10:58:47 |
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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
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
riku_hamada@tmhp.jp
Sponsor or person
Institute
Tokyo Metropolitan Children's Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002147
