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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004831
Receipt No. 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

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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
Email

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
Email k-yanagi@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki evaluation organization for clinical interventions
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005749

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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