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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000013446
Receipt No. R000015703
Scientific Title The prospective observational study to evaluate a swallowing function and the efficacy of macrolide antibiotics combination therapy in patients with community-acquired pneumonia
Date of disclosure of the study information 2014/03/19
Last modified on 2014/03/17

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Basic information
Public title The prospective observational study to evaluate a swallowing function and the efficacy of macrolide antibiotics combination therapy in patients with community-acquired pneumonia
Acronym Study of swallowing functions and macrolides combination therapy in community acquired therapy
Scientific Title The prospective observational study to evaluate a swallowing function and the efficacy of macrolide antibiotics combination therapy in patients with community-acquired pneumonia
Scientific Title:Acronym Study of swallowing functions and macrolides combination therapy in community acquired therapy
Region
Japan

Condition
Condition Community-acquired pneumonia
Classification by specialty
Pneumology Infectious disease Geriatrics
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate prospectively a swallowing function in patients acquired hospitalizations due to pneumonia and the efficacy of macrolide antibiotics combination therapy in the treatment of pneumonia
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 30-day and 90-day mortality rates after the admission
Key secondary outcomes

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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with community-acquired pneumonia(CAP), the definition; 1)infiltrates consistent with CAP seen on a chest radiography, 2)clinical features consistent with CAP, 3)a strong possibility of the affection outside a hospital or long-term care facility.
Key exclusion criteria 1)patients having difficulty in agreement due to consciousness disturbance with no key person, 2)patients with interstitial pneumonia or nontuberculous mycobacterial infections or fungal infections or pulmonary embolism or pneumothorax or pyothorax or severe heart failure
3)hospital-acquired pneumonia(pneumonia that occurs 48 hours or more after hospital admission and that was not present at the time of admission.)
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki Oka
Organization Tenshindo Hetsugi Hospital
Division name Clinical Research Center of Respiratory Medicine
Zip code
Address 5956, Nihongi, Nakahetsugi, Oita-shi, Oita, 879-7761, Japan
TEL 097-597-5777
Email m10d9007@oita-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroaki Oka
Organization Tenshindo Hetsugi Hospital
Division name Clinical Research Center of Respiratory Medicine
Zip code
Address 5956, Nihongi, Nakahetsugi, Oita-shi, Oita, 879-7761, Japan
TEL 097-597-5777
Homepage URL
Email m10d9007@oita-u.ac.jp

Sponsor
Institute Tenshindo Hetsugi Hospital
Institute
Department

Funding Source
Organization Tenshindo Hetsugi Hospital
Organization
Division
Category of Funding Organization Self funding
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
2014 Year 03 Month 19 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 Open public recruiting
Date of protocol fixation
2013 Year 12 Month 18 Day
Date of IRB
Anticipated trial start date
2014 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective observational study

Management information
Registered date
2014 Year 03 Month 17 Day
Last modified on
2014 Year 03 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015703

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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