UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017459 |
|---|---|
| Receipt number | R000020225 |
| Scientific Title | Early discontinuation of antibiotic prophylaxis in patients with persistent p rimary vesicoureteral reflux initially detected during infancy: outcome analys is and risk factors for febrile urinary tract infection |
| Date of disclosure of the study information | 2015/05/08 |
| Last modified on | 2015/05/08 11:31:12 |
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Basic information
Public title
Early discontinuation of antibiotic prophylaxis in patients with persistent p
rimary vesicoureteral reflux initially detected during infancy: outcome analys
is and risk factors for febrile urinary tract infection
Acronym
Early discontinuation of antibiotic prophylaxis in patients with persistent p
rimary vesicoureteral reflux initially detected during infancy: outcome analys
is and risk factors for febrile urinary tract infection
Scientific Title
Early discontinuation of antibiotic prophylaxis in patients with persistent p
rimary vesicoureteral reflux initially detected during infancy: outcome analys
is and risk factors for febrile urinary tract infection
Scientific Title:Acronym
Early discontinuation of antibiotic prophylaxis in patients with persistent p
rimary vesicoureteral reflux initially detected during infancy: outcome analys
is and risk factors for febrile urinary tract infection
Region
| Japan |
Condition
Condition
primary vesicoureteral reflux
Classification by specialty
| Pediatrics | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We retrospectively assessed the incidence of and risk factors for febrile urinary tract infection in children during active surveillance after early discontinuation of antibiotic prophylaxis.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
incidence of febrile urinary tract infection and assessment of risk factors for febrile urinary tract infection after discontinuation of continuous antibiotics prophylaxis
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients who had persistent VUR on followup VCUG and were subsequently followed under active surveillance without CAP
Key exclusion criteria
Patients with secondary VUR or associated abnormality such as ureterocele, ectopic ureter, concomitant ureteropelvic junction obstruction, multicystic dysplastic kidney, posterior urethral valve or neurogenic bladder
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kimihiko Moriya |
Organization
Hokkaido University Hospital
Division name
Department of Renul and Genitourinary surgery
Zip code
Address
Kita 14, Nishi 5,Kita-ku Sapporo,Hokkaido,japan
TEL
011-706-5966
k-moriya@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kimihiko Moriya |
Organization
Hokkaido University Hospital
Division name
Department of Renul and Genitourinary surgery
Zip code
Address
Kita 14, Nishi 5,Kita-ku Sapporo,Hokkaido,japan
TEL
011-706-5966
Homepage URL
k-moriya@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2015 | Year | 05 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2014 | Year | 01 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 08 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective study
Management information
Registered date
| 2015 | Year | 05 | Month | 08 | Day |
Last modified on
| 2015 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020225
