UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002234 |
|---|---|
| Receipt number | R000002583 |
| Scientific Title | Inspection for the management guidelines of acute respiratory infection in adults |
| Date of disclosure of the study information | 2009/07/22 |
| Last modified on | 2011/07/22 09:43:17 |
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Basic information
Public title
Inspection for the management guidelines of acute respiratory infection in adults
Acronym
Inspectional study of Respiratory tract infection (Pulmonary Disease)
Scientific Title
Inspection for the management guidelines of acute respiratory infection in adults
Scientific Title:Acronym
Inspectional study of Respiratory tract infection (Pulmonary Disease)
Region
| Japan |
Condition
Condition
The patients of acute upper respiratory tract infection including acute bronchitis.
Classification by specialty
| Medicine in general | Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To appropriate usage of antibiotics, we will survey to actual usage of them, and evaluate the necessity in acute pharyngitis, acute tonsillitis, and acute bronchitis.
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
The patients of acute upper respiratory tract infection including acute bronchitis (Acute tonsilitis, acute Pharngitis)
Adult patients (>= 20years) in rule
Key exclusion criteria
Patients whose diseases have taboo against the used antibiotics.
When you use ntibiotics,patients who have been owns allergy medical history or allergy familial history.
Patients whose diseases have been judged as severe (oral adoption insufficient patients, non-oral nutrition patients, etc)
Patients suffering severe kidney dysfunction
who have been judged influenza or typical bacterial infections.
Target sample size
3000
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=R000002583
