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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008677
Receipt No. 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

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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
Email 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
Email satake64kbps@mbn.nifty.com

Sponsor
Institute Second Division, Department of Internal Medicine, Hamamatsu university school of medicine
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009985

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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