UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013446 |
|---|---|
| Receipt number | 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 23:52:11 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
m10d9007@oita-u.ac.jp
Sponsor or person
Institute
Tenshindo Hetsugi Hospital
Institute
Department
Personal name
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
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
Value
https://center6.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 |
