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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002232
Receipt No. R000002333
Scientific Title Compliance Survey of Multiple Oral Antibiotics
Date of disclosure of the study information 2009/07/22
Last modified on 2011/11/28

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Basic information
Public title Compliance Survey of Multiple Oral Antibiotics
Acronym COSMOS
Scientific Title Compliance Survey of Multiple Oral Antibiotics
Scientific Title:Acronym COSMOS
Region
Japan

Condition
Condition Outpatients who are diagnosed Upper respiratory inflammation Lower respiratory inflammation and Otitis
Classification by specialty
Medicine in general Pneumology Infectious disease
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm compliance with oral antibiotic therapy for acute community infections and patient background associated with non-compliance in Japan
Basic objectives2 Others
Basic objectives -Others Drug compliance
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Drug compliance
Key secondary outcomes Reason for non-compliance
A symptom at the time of the taking medicine end for Drug non-compliance patients
Co-relation between non-compliance and reason as below
The severity of the underlying disease a day
Prescription term and number of dose a day
Explanation by doctor
Explanation by pharmacist

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patient who is diagnosed as either of the following diseases, and prescribed oral antibiotics.
Pneumonia
Acute bronchial
Pharyngitis or tonsillitis
Sinusitis
Otitis media
The secondary infection of the chronic respiratory disease (chronic obstructive pulmonary disease, chronic bronchitis, asthma, and diffuse panbronchialitis, etc.)
Key exclusion criteria Patients whom the investigator considers as inappropriate to join the study.
Known previous hypersensitivity to antibiotics.
Target sample size 1500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeru Kohno
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name Department of Molecular Microbiology and Immunology
Zip code
Address 1-12-4, Sakamoto, Nagasaki city, Nagasaki prefecture.
TEL 095-819-7001
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihiro Yamamoto
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 yamamoto-ngs@umin.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 07 Month 17 Day
Date of IRB
Anticipated trial start date
2008 Year 08 Month 01 Day
Last follow-up date
2009 Year 07 Month 01 Day
Date of closure to data entry
2009 Year 08 Month 01 Day
Date trial data considered complete
2009 Year 10 Month 01 Day
Date analysis concluded
2009 Year 12 Month 01 Day

Other
Other related information Retrospective study
Outcome variable:
Compliance survey

Management information
Registered date
2009 Year 07 Month 22 Day
Last modified on
2011 Year 11 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002333

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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