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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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


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

Value
https://center6.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