UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of the efficacy and safety of high-dose clarithromycin in adult patients with community-acquired pneumonia-multicenter,single-group,open-label study
Title of the study (Brief title)	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	Yoshihito Niki
Organization	School of medicine, Showa university
Division name	Department of medicine,Division of clinical infectious diseases
Address	1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555,Japan
TEL	03-3784-8777
Email	niki@med.showa-u.ac.jp

Public contact
Name of contact person	Community-acquired pneumonia study secretariat
Organization	Satt Co., Ltd.
Division name	Clinical Research Group
Address	Urban Prem Shinjuku 5th floor2-12-8 Shinjuku, Shinjuku-ku, Tokyo 160-0022,Japan,
TEL	03-5312-5026
Homepage URL
Email	pneumonia@sa-tt.co.jp

Sponsor
Institute	Department of medicine, Division of clinical infectious diseases, School of medicine, Showa university
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018886