UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010192 |
|---|---|
| Receipt number | R000011937 |
| Scientific Title | Clinical efficacy of doripenem(3g daily)against patients with obstructive pyelonephritis caused by ureteral calculi. |
| Date of disclosure of the study information | 2013/03/10 |
| Last modified on | 2015/07/09 21:10:44 |
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Basic information
Public title
Clinical efficacy of doripenem(3g daily)against patients with obstructive pyelonephritis caused by ureteral calculi.
Acronym
Clinical efficacy of doripenem(3g daily)against patients with obstructive pyelonephritis caused by ureteral calculi.
Scientific Title
Clinical efficacy of doripenem(3g daily)against patients with obstructive pyelonephritis caused by ureteral calculi.
Scientific Title:Acronym
Clinical efficacy of doripenem(3g daily)against patients with obstructive pyelonephritis caused by ureteral calculi.
Region
| Japan |
Condition
Condition
Obstructive pyelonephritis caused by ureteral calculi.
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarify the efficacy of doripenem against the patients with obstructive pyelonephritis caused by ureteral calculi.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Period from initiation of therapy to alleviation of fever.
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Doripenem 3g daily
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)2)age:20 years old or older.male and female.
3)hospitalized patients.
4)Obstructive urinary tract due to urolithiasis.
5,6)Patients showing clinical symptoms such as high fever ,miction pain,back pain,etc.
7)pyuria:white blood cells five/hpf or more in urinary sediment.
8)bacteriuria:104 CFU/mL in catheterized urine or105 CFU/mL in midstream urine.
Key exclusion criteria
1)patient wiht prostatitis or epididymitis.
2)patient with urinary diversion.
3)patient was administered other antimicrobials and their symptom has been improved before starting administration of doripenem.
4)patient with severe underlying disease or complications, who cannot be evaluated efficacy and safety of doripenem.
5)patient with carbapenem allergies.
6)patient with severe cardiac or hepatic dysfunction.
7)patient with moderate renal dysfunction (criteria:serum creatinine>=2mg/dL)
8)patient with convulsive disorders such as epilepsy.
9)Pregnant women or females with childbearing potential.
10)patient disqualified as target by doctor.
11)Doripenem resistant pathogen has been already isolated.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi kiyota |
Organization
Jikei university katsushika medical center
Division name
Department of urology
Zip code
Address
6-41-2,aoto,katsushika-ku,tokyo
TEL
0336032111
kirasin1031@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | shinichiro kira |
Organization
Jikei university katsushika medical center
Division name
Department of urology
Zip code
Address
6-41-2,aoto,katsushika-ku,tokyo
TEL
0336032111
Homepage URL
kirasin1031@yahoo.co.jp
Sponsor or person
Institute
Jikei university katsushika medical center,Department of urology
Institute
Department
Personal name
Funding Source
Organization
Jikei university school of medicine,Department of urology
Organization
Division
Category of Funding Organization
Other
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
| 2013 | Year | 03 | Month | 10 | 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
Completed
Date of protocol fixation
| 2012 | Year | 07 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2015 | Year | 07 | Month | 06 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 08 | Day |
Last modified on
| 2015 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011937
