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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002234
Receipt No. 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

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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
Email

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
Email seki@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 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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002583

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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