UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003216 |
|---|---|
| Receipt number | R000003898 |
| Scientific Title | Evaluation of the efficacy of biapenem for complicated urinary tract infections and the pharmacokinetic-pharmacodynamic parameter |
| Date of disclosure of the study information | 2010/02/22 |
| Last modified on | 2011/12/17 00:07:03 |
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Basic information
Public title
Evaluation of the efficacy of biapenem for complicated urinary tract infections and the pharmacokinetic-pharmacodynamic parameter
Acronym
Evaluation of the efficacy of biapenem for complicated urinary tract infections and the pharmacokinetic-pharmacodynamic parameter
Scientific Title
Evaluation of the efficacy of biapenem for complicated urinary tract infections and the pharmacokinetic-pharmacodynamic parameter
Scientific Title:Acronym
Evaluation of the efficacy of biapenem for complicated urinary tract infections and the pharmacokinetic-pharmacodynamic parameter
Region
| Japan |
Condition
Condition
complicated urinary tract infections
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Search for optimum PK-PD parameter of biapenem for complicated urinary tract infections.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The decision of the PK-PD parameter of biapenem which is effective for complicated urinary infections disease
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.patients who are admitted to Gifu University Hospital with complicated urinary tract infections
2.20 years old or older
3.written informed consent must be obtained from patients
Key exclusion criteria
1.The patients who need surgical management or drainage
2.any severe rapidly progressive disease(ex. Central Nerve System disease,advanced malignant neoplasms)
3.Case clearly has a poor prognosis
4.inadequate liver or renal function
6.history of serious allergy to study therapy
7.case that valproic acid formulation (anticonvulsant) is given to or the case with the central nerve disorder such as epilepsy
8.pregnancy orlactation in women
9.treatment with a systemic antimicrobial agent prior to the baseline urine culture
10.The case (chlamydia, a fungus) that the effect of the study drug is hard to expect from an aspect of the susceptibility for an infection due to the pathogen resistant in BIPM
11.Patients with prostatic hyperplasia postoperative infection that occurred (TUR-P) within one month (however, it is assumed that the patients whom total prostatectomy was performed in by prostate cancer are possible)
12. The patients (however, it is assumed that the patients whom ureterocutaneous fistula technique was performed in are possible) whom intestinal use urinary diversion technique (ileal conduits) was performed in
13.Urethritis, prostatitis, epididymitis
perinephric or intrarenal abscess
14.The case that excluded by the judgment of the person in charge
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kensaku Seike |
Organization
Gifu University Graduate School of Medicine
Division name
Department of Urology
Zip code
Address
1-1 Yanagido, Gifu City, Gifu 501-1194, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kensaku Seike |
Organization
Gifu University Graduate School of Medicine
Division name
Department of Urology
Zip code
Address
1-1 Yanagido, Gifu City, Gifu 501-1194, Japan
TEL
Homepage URL
k.seike-04.6.26@leaf.ocn.ne.jp
Sponsor or person
Institute
Department of Urology,Gifu University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Urology,Gifu University Graduate School of Medicine
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
岐阜大学医学部附属病院（岐阜県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 02 | Month | 22 | 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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 02 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 03 | Month | 01 | Day |
Other
Other related information
Measure a blood level of biapenem
Measure urinary biapenem concentration
Evaluate a clinical response of biapenem
Temperature, in-urine white blood cells, white blood corpuscle, CRP
Management information
Registered date
| 2010 | Year | 02 | Month | 20 | Day |
Last modified on
| 2011 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003898
