UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004077 |
|---|---|
| Receipt number | 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 09:16:28 |
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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
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
y-tanabe@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University Medical & Dental Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004909
