UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016277 |
|---|---|
| Receipt number | R000018886 |
| Scientific Title | Investigation of the efficacy and safety of high-dose clarithromycin in adult patients with community-acquired pneumonia-multicenter,single-group,open-label study |
| Date of disclosure of the study information | 2015/01/20 |
| Last modified on | 2016/08/05 21:44:27 |
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Basic information
Public title
Investigation of the efficacy and safety of high-dose clarithromycin in adult patients with community-acquired pneumonia-multicenter,single-group,open-label study
Acronym
Investigation of the efficacy and safety of high-dose clarithromycin in adult patients with community-acquired pneumonia
Scientific Title
Investigation of the efficacy and safety of high-dose clarithromycin in adult patients with community-acquired pneumonia-multicenter,single-group,open-label study
Scientific Title:Acronym
Investigation of the efficacy and safety of high-dose clarithromycin in adult patients with community-acquired pneumonia
Region
| Japan |
Condition
Condition
Adult community-acquired pneumonia
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of the efficacy and safety of high-dose clarithromycin in adult patients with community-acquired pneumonia (bacterial pneumonia or mycoplasma pneumonia)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Based on clinical findings from observations and laboratory tests, the clinical efficacy of the investigational drug will be determined at the completion or discontinuation of treatment, in accordance with the guidelines for assessment of effectiveness of pneumonia treatment established by the Japanese Society of Chemotherapy.
All adverse events during the treatment period (from the start of treatment with investigational drug until the completion or discontinuation of treatment with investigational drug) will be investigated.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Clarithromycin is orally administered at a daily dosage of 800 mg in two divided doses. The administration period is between 4 and 14 days.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients with mild or moderate community-acquired pneumonia in accordance with the JRS guidelines for severity
(2) The patient's pneumonia is suspected to be caused by either pneumococcus, Hemophilus influenza or Mycoplasma pneumonia, or is either suspected bacterial pneumonia or mycoplasma pneumonia in accordance with the JRS guidelines.
(3) Patients who can visit the hospital
(4) Patients who can provide informed consent in writing
Key exclusion criteria
Patients who have previously experienced anaphylaxis reactions to the investigational drug or other drugs
(2) Patients who are treated with pimozide- or ergotamine-containing drugs or tadalafil
(3) Patients determined to be ineligible for the study due to liver disease, kidney disease, heart disease or other serious complications
(4) Pregnant or lactating females and females who are suspected of being pregnant
(5) Patients assessed by the principal investigator or sub-investigator as
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihito Niki |
Organization
School of medicine, Showa university
Division name
Department of medicine,Division of clinical infectious diseases
Zip code
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555,Japan
TEL
03-3784-8777
niki@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Community-acquired pneumonia study secretariat |
Organization
Satt Co., Ltd.
Division name
Clinical Research Group
Zip code
Address
Urban Prem Shinjuku 5th floor2-12-8 Shinjuku, Shinjuku-ku, Tokyo 160-0022,Japan,
TEL
03-5312-5026
Homepage URL
pneumonia@sa-tt.co.jp
Sponsor or person
Institute
Department of medicine,
Division of clinical infectious diseases,
School of medicine, Showa university
Institute
Department
Personal name
Funding Source
Organization
Taisho Toyama Pharm. Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
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
社会福祉法人恩賜財団済生会 山形済生病院（山形県）
医療法人社団 尽徳会 酒寄医院（東京都）
川崎医科大学附属川崎病院（岡山県）
大分県厚生連 鶴見病院（大分県）
たかはしクリニック（熊本県）
内尾土井クリニック（熊本県）
野津手・加来内科医院（宮崎県）
北浦診療所（宮崎県）
木谷医院（宮崎県）
一般財団法人杏仁会 江南病院（熊本県）
山本内科クリニック（熊本県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 20 | 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
| 2014 | Year | 10 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 20 | Day |
Last modified on
| 2016 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018886
