UMIN-CTR Clinical Trial

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
Last 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
Email	sai-mari@oita-u.ac.jp

Public contact
1st 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
Email	sai-mari@oita-u.ac.jp

Sponsor
Institute	Department of Respiratory Medicine and Infectious Diseases, Oita University Faculty of Medicine
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025429