UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004831 |
|---|---|
| Receipt number | R000005749 |
| Scientific Title | Validation of "Clinical evaluation methods for new antibacterial drugs to treat respiratory infections" (second version) |
| Date of disclosure of the study information | 2011/01/06 |
| Last modified on | 2011/07/22 09:42:10 |
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Basic information
Public title
Validation of "Clinical evaluation methods for new antibacterial drugs to treat respiratory infections" (second version)
Acronym
Validation of "Clinical evaluation methods for new antibacterial drugs to treat respiratory infections" (second version)
Scientific Title
Validation of "Clinical evaluation methods for new antibacterial drugs to treat respiratory infections" (second version)
Scientific Title:Acronym
Validation of "Clinical evaluation methods for new antibacterial drugs to treat respiratory infections" (second version)
Region
| Japan |
Condition
Condition
Community-acquired bacterial pneumonia
Classification by specialty
| Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
"Clinical evaluation methods for new antimicrobial agents to treat respiratory infections" (issued in 1997) is being revised. "Clinical evaluation methods for new antibacterial drugs to treat respiratory infections" (second version) is scheduled to be published soon.
We will validate "Clinical evaluation methods for new antibacterial drugs to treat respiratory infections" (second version) by treating patients with community-acquired pneumonia in the normal clinical setting and assessing effects in accordance with the recommendations of "Clinical evaluation methods for new antibacterial drugs to treat respiratory infections"(second version).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Clinical response at the test-of-cure (TOC) visit.
Key secondary outcomes
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
1) Levofloxacin (500 mg) is administered orally or intravenously (over approximately 60 minutes) once daily. The administration route can be switched from intravenous to oral during the treatment period.
2) The drug is administered every day for 7-14 days, and is stopped when the therapeutic goal is attained or if administration has to be discontinued.
3) In patients with decreased renal function, the dosage and administration described below is basically used, but the dose and administration interval can be varied as necessary.
20mL/min <= Ccr < 50mL/min :500 mg initial dose, then 250 mg every 24 hours.
Ccr < 20mL/min :500 mg initial dose, then 250 mg every 48 hours.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who the investigator judges to be suitable for treatment with antibacterial drugs.
2) Acute infiltrative changes are detected by chest X-ray or CT within the previous 48 hours and the investigator suspects community-acquired pneumonia from observation including at least one of the clinical symptoms/findings listed below:
- Cough
- Purulent sputum or increased purulence of sputum.
- Abnormal findings on auscultation (including moist rales, dull breath sounds, and decreased breath sounds).
- Dyspnea or/and tachypnea.
- Fever (axillary temperature):37 degrees or more in temperature.
- Increased white blood cell count (>10,000/mm3), stab leucocytes >15%, or decreased white blood cell count (<4,500/mm3).
- Increase of CRP.
- Hypoxemia
Key exclusion criteria
1) Patients with bronchial obstruction or those who have a past history of obstructive pneumonia (excluding COPD patients).
2) Patients with primary lung cancer or those who have pulmonary metastasis.
3) Patients with cystic fibrosis, AIDS, pneumocystis pneumonia (including suspected pneumocystis pneumonia), or active pulmonary tuberculosis (including suspected active pulmonary tuberculosis).
4) Patients with suspected atypical pneumonia.
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeru Kohno |
Organization
Nagasaki University Hospital
Division name
director
Zip code
Address
1-7-1, Sakamoto, Nagasaki city, Nagasaki prefecture.
TEL
095-819-7273
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsunori Yanagihara |
Organization
Nagasaki University Hospital
Division name
Department of Laboratory Medicine
Zip code
Address
1-7-1, Sakamoto, Nagasaki city, Nagasaki prefecture.
TEL
095-819-7418
Homepage URL
k-yanagi@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki evaluation organization for clinical interventions
Institute
Department
Personal name
Funding Source
Organization
Nagasaki evaluation organization for clinical interventions
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 01 | Month | 06 | 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 | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 01 | Month | 06 | Day |
Last modified on
| 2011 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005749
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