UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004077
Receipt No. R000004909
Scientific Title Investigation of an Optimum Dosing Method of Levofloxacin 500 mg in Patients receiving Hemodialysis
Date of disclosure of the study information 2010/08/20
Last modified on 2013/07/09

* 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 Investigation of an Optimum Dosing Method of Levofloxacin 500 mg in Patients receiving Hemodialysis
Acronym Investigation of an Optimum Dosing Method of Levofloxacin 500 mg in Patients receiving Hemodialysis
Scientific Title Investigation of an Optimum Dosing Method of Levofloxacin 500 mg in Patients receiving Hemodialysis
Scientific Title:Acronym Investigation of an Optimum Dosing Method of Levofloxacin 500 mg in Patients receiving Hemodialysis
Region
Japan

Condition
Condition bacterial infection
Classification by specialty
Medicine in general Nephrology Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To measure blood levels following the administration of levofloxacin at a new dose level (500 mg/dose once daily) in dialysis patients receiving antibacterial agents for the treatment of infections, and to investigate the optimum dose level in patients receiving hemodialysis.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Blood level of levofloxacin (Comparison of time course of residual blood level with non-dialysis patients as previously reported)
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Patients receiving chronic dialysis during the study period, having infection, and selected LVFX treatment;
2)Patients competent to issue informed consent and having the intention to participe in the study (consent by a proxy consenter is also acceptable).
Key exclusion criteria Patients hypersensitive to quinolones.
Pregnant women or women of child bearing potential.
Children under 18 years old.
Patients with liver cirrhosis.
Blood albumin level is 3g/dl or less.
Patients receiving preparations containing iron, magnesium or aluminum with some particular methods;
Patients whose weight is less than 40 kg;
Patients with infection which is already known that the pathogen is unresponsive to LVFX, and the bacterial strain is clinically evidently ineffective;
Other patients judged by the investigator or the sub-investigator as inappropriate for the study.

Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshinari TANABE
Organization Niigata University Medical & Dental Hospital
Division name Division of Infection Control and Prevention
Zip code
Address 1-754 Asahimachi-dori, Niigata 951-8510,Japan
TEL +81-25-227-2200
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Niigata University Medical & Dental Hospital
Division name Division of Infection Control and Prevention
Zip code
Address
TEL
Homepage URL
Email y-tanabe@med.niigata-u.ac.jp

Sponsor
Institute Niigata University Medical & Dental Hospital
Institute
Department

Funding Source
Organization Niigata University Medical & Dental Hospital
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 Niigata University Medical & Dental Hospital

Other administrative information
Date of disclosure of the study information
2010 Year 08 Month 20 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
2010 Year 07 Month 06 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 01 Day
Last follow-up date
2011 Year 01 Month 01 Day
Date of closure to data entry
2011 Year 01 Month 01 Day
Date trial data considered complete
2011 Year 01 Month 01 Day
Date analysis concluded
2012 Year 01 Month 01 Day

Other
Other related information Blood level of levofloxacin
Body temperature
Hematological test (blood cell counting and biochemical parameters) before the next session of dialysis after the end of treatment.

Management information
Registered date
2010 Year 08 Month 20 Day
Last modified on
2013 Year 07 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004909

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.