UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008677 |
|---|---|
| Receipt number | R000009985 |
| Scientific Title | Efficacy and Safety of treatment with Levofloxacin for Community-acquired Pneumonia |
| Date of disclosure of the study information | 2012/08/14 |
| Last modified on | 2016/08/19 18:10:09 |
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Basic information
Public title
Efficacy and Safety of treatment with Levofloxacin for Community-acquired Pneumonia
Acronym
Levofloxacin Therapy for Community-acquired Pneumonia
Scientific Title
Efficacy and Safety of treatment with Levofloxacin for Community-acquired Pneumonia
Scientific Title:Acronym
Levofloxacin Therapy for Community-acquired Pneumonia
Region
| Japan |
Condition
Condition
Community-acquired pneumonia in adults
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy and safety levofloxacin therapy for community-acquired pneumonia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical effectiveness at seven days after the end of treatment.
Key secondary outcomes
Clinical and bacteriological effectiveness at the end of treatment. mortality, hospitalization, adverse event.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Levofloxacin is given intravenously at 500mg/body for 3days. If the improvement is obtained, change from intravenous to oral intake.
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.Subjects are aged >= 18.
2.Subjects require treatment with intravenous antibiotics injection.
3.Patients who are diagnosed with community-acquired pneumonia including clinical findings listed below:
1)Fever (>=37 degrees Celsius), white blood cell count >9000/mm3, stab leucocytes >=15%, CRP >=0.5mg/dl.
2)Cough. Purulent sputum, Dyspnea, Chill, Chest pain, rales.
3)New infiltrative shadow on a chest X-ray
Key exclusion criteria
1.Patients who took respiratory quinolones for current pneumonia.
2.Patients who are prohibited to take levofloxacin.
3.Patients with liver dysfunction
AST:more than three times the upper limit of normal
ALT:more than three times the upper limit of normal
T-bil:more than three times the upper limit of normal
4.Patients witg renal dysfunction (Cre is over than 3.0mg/dl, or Ccr is less than 30 mL/min/1.73m2)
5.Patients who has disease of central nervous system and expected spasm.
6.Patient whom conducting of the examination doctor judged inappropriate.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takafumi Suda |
Organization
Hamamatsu University School of Medicine
Division name
Second division,Department of Internal Medicine
Zip code
Address
1-20-1,Handayama,Higashiku,Hamamatsu,Shizuoka,433-8112,Japan
TEL
053-435-2263
satake64kbps@mbn.nifty.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuomi Satake |
Organization
Hamamatsu University School of Medicine
Division name
Second division,Department of Internal Medicine
Zip code
Address
1-20-1,Handayama,Higashiku,Hamamatsu,Shizuoka,433-8112,Japan
TEL
053-435-2263
Homepage URL
satake64kbps@mbn.nifty.com
Sponsor or person
Institute
Second Division, Department of Internal Medicine, Hamamatsu university school of medicine
Institute
Department
Personal name
Funding Source
Organization
Second Division, Department of Internal Medicine, Hamamatsu university school of medicine
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 14 | 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
| 2012 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 12 | Day |
Last modified on
| 2016 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009985
