UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002235 |
|---|---|
| Receipt number | R000002653 |
| Scientific Title | Inspection for the management guidelines of chronic respiratory infection in adults |
| Date of disclosure of the study information | 2009/07/22 |
| Last modified on | 2011/07/22 09:43:52 |
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Basic information
Public title
Inspection for the management guidelines of chronic respiratory infection in adults
Acronym
Inspectional study of Respiratory tract infection (Pulmonary Disease)
Scientific Title
Inspection for the management guidelines of chronic respiratory infection in adults
Scientific Title:Acronym
Inspectional study of Respiratory tract infection (Pulmonary Disease)
Region
| Japan |
Condition
Condition
Secondary infections of Chronic respiratory illness.
Classification by specialty
| Medicine in general | Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To not only survey for actual usage for secondary infection of chronic respiratory illness, including acute exacerbations of chronic bronchitis, bronchial asthma+infection, emphysema+infection, pneumonicosis+infection, old tuberculosis+infection, interstitial pnemonitis+infection, but also evaluation of efficiency and safety of antibiotics.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Efficacy and safety.
Key secondary outcomes
Antimicrobial efficacy
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult patients (<=20years)
Mild to moderate severity patients
At the time of antibiotics
administration, the patients who included following criteria: either fever 37.0 degrees Celsius, purulent sputum, WBC>8000/mm3, or CRP 0.7mg/dL.
The patients who understand the purpose of this study and side effects of drugs, and who declare their (including family) own will to participate this study orally or by documents (The doctors have to get the patients' agreements under facilities rules before entry to study. In case, certificates of patients' agreements will be necessary).
Key exclusion criteria
Patients whose diseases have taboo against the used antibiotics(See attached files).
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeru Kohno |
Organization
Nagasaki University
Division name
School of Medicine
Zip code
Address
1-7-1, Sakamoto, Nagasaki city, Nagasaki prefecture.
TEL
095-819-7418
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masafumi Seki |
Organization
Nagasaki University
Division name
School of Medicine
Zip code
Address
1-7-1, Sakamoto, Nagasaki city, Nagasaki prefecture.
TEL
095-819-7273
Homepage URL
seki@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
Non profit foundation
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 07 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2008 | Year | 04 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 06 | Month | 01 | Day |
Other
Other related information
Prospective study
Outcome variable:
Efficiency and safety.
Management information
Registered date
| 2009 | Year | 07 | Month | 22 | 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=R000002653
