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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000003216
Receipt No. 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

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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
Email

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
Email k.seike-04.6.26@leaf.ocn.ne.jp

Sponsor
Institute Department of Urology,Gifu University Graduate School of Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003898

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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