UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023355 |
|---|---|
| Receipt number | R000025429 |
| Scientific Title | Effect of long-term clarithromycin antibiotic therapy on preventation of pneumonia in the elderly: a prospective randomised controlled trial. |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2019/03/29 11:26:42 |
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Basic information
Public title
Effect of long-term clarithromycin antibiotic therapy on preventation of pneumonia in the elderly: a prospective randomised controlled trial.
Acronym
Effect of long-term clarithromycin antibiotic therapy on preventation of pneumonia in the elderly: a prospective randomised controlled trial.
Scientific Title
Effect of long-term clarithromycin antibiotic therapy on preventation of pneumonia in the elderly: a prospective randomised controlled trial.
Scientific Title:Acronym
Effect of long-term clarithromycin antibiotic therapy on preventation of pneumonia in the elderly: a prospective randomised controlled trial.
Region
| Japan |
Condition
Condition
pneumonia
Classification by specialty
| Pneumology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Can long-term macrolide antibiotic therapy prevent the development of pneumonia in elderly people?
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of pneumonia
Key secondary outcomes
TTime to pneumonia recurrence
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
administration of clarithromycin, 200mg/day, 1 year
Interventions/Control_2
control
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients 65 years of age and older
2) Patients who has the past of pneumonia
Key exclusion criteria
1) Patients under 65 years old
2) Patients with a history of the past of hypersensitivity for an ingredient of the clarithromycin
3) Patients having serious complications
4) Patients who is taking the drug that blood levels changes by clarithromycin
5) Patients who is already giving antimicrobial including the macrolide
6) Patients having nontuberculous acid-fast bacterial disease
7) Patients who judged the physician to be inappropriate for this study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mari Yamasue |
Organization
Oita University Faculty of Medicine
Division name
Department of Respiratory Medicine and Infectious Diseases
Zip code
Address
1-1 Idaigaoka, Hasama, Yufu, Oita
TEL
097-549-4411
sai-mari@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mari Yamasue |
Organization
Oita University Faculty of Medicine
Division name
Department of Respiratory Medicine and Infectious Diseases
Zip code
Address
1-1 Idaigaoka, Hasama, Yufu, Oita
TEL
097-549-4411
Homepage URL
sai-mari@oita-u.ac.jp
Sponsor or person
Institute
Department of Respiratory Medicine and Infectious Diseases, Oita University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Taisho Toyama Pharmaceutical Co
Organization
Division
Category of Funding Organization
Other
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
| 2016 | Year | 08 | Month | 01 | 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
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 08 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 14 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 14 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 27 | Day |
Last modified on
| 2019 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025429
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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