UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014457 |
|---|---|
| Receipt number | R000016816 |
| Scientific Title | Study on PK-PD and TDM of Levofloxicin |
| Date of disclosure of the study information | 2014/07/02 |
| Last modified on | 2020/08/06 06:45:22 |
* 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
Study on PK-PD and TDM of Levofloxicin
Acronym
Study on PK-PD & TDM of LVFX
Scientific Title
Study on PK-PD and TDM of Levofloxicin
Scientific Title:Acronym
Study on PK-PD & TDM of LVFX
Region
| Japan |
Condition
Condition
Infectious disease
Classification by specialty
| Infectious disease | Surgery in general | Obstetrics and Gynecology |
| Pediatrics | Dermatology | Oto-rhino-laryngology |
| Orthopedics | Urology | Neurosurgery |
| Cardiovascular surgery | Plastic surgery | Aesthetic surgery |
| Laboratory medicine | Operative medicine | Emergency medicine |
| Intensive care medicine | Adult | Child |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify effectiveness of PK-PD analysis and TDM of levofloxicin
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Ratio of 24h-AUC to MIC and clinical laboratory data and findings related to infection
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
| 10 | years-old | <= |
Age-upper limit
| 110 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Inpatients treated with levofloxicin.
Key exclusion criteria
Nothing
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kimikazu Shinozaki |
Organization
Kitasato Institute Hospital
Division name
Division of TDM
Zip code
Address
5-9-1 Shirokane, Minato-ku
TEL
03-5791-6232
shinozakik@pharm.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kimikazu Shinozaki |
Organization
Kitasato Institute Hospital
Division name
Division of TDM
Zip code
Address
5-9-1 Shirokane, Minato-ku
TEL
03-5791-6232
Homepage URL
shinozakik@pharm.kitasato-u.ac.jp
Sponsor or person
Institute
Division of TDM, Kitasato Institute Hospital
Institute
Department
Personal name
Funding Source
Organization
Pharmacokintic Labo., Cenyer for Clinical Pharmacy and Sciences, School of Pharmacy, Kitasato Univeersity
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
北里研究所病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | Month | 02 | 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
| 2014 | Year | 07 | Month | 02 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2014 | Year | 08 | Month | 11 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing
Management information
Registered date
| 2014 | Year | 07 | Month | 02 | Day |
Last modified on
| 2020 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016816
