臨床研究等提出・公開システム

Japanese

Date of registration	Aug. 01, 2012
Last modified on	July. 30, 2015
Trial ID	jRCT1090220095

Scientific Title	Prospective observational study of azithromycin in patients with acute exacerbation of fibrosing interstitial pneumonia
Public Title	Prospective observational study of azithromycin in patients with acute exacerbation of fibrosing interstitial pneumonia

Study end date
Performed Number of Subjects
Baseline Characteristics
Participant Flow
Safety Conclusions
Efficacy Conclusions
Discussion and Overall Conclusions
Posted Date
Date of First Publication
Results Links	http://www.karger.com/Article/FullText/358443

Plan to Share IPD
Plan Description
Protocol Links

Contact for Scientific Queries	Investigator Name	kodai kawamura
	Investigator Organization	Saiseikai kumamoto hospital
	Address	Chikami 5-3-1, minami-ku, Kumamoto, kumamoto, 8614193, Japan
	TEL	+81-96-351-8000
	E-mail	kodai-kawamura@saiseikaikumamoto.jp
Contact for Public Queries	Contact Name	kodai kawamura
	Contact Organization	Saiseikai kumamoto hospital
	Address	Chikami 5-3-1, minami-ku, Kumamoto, kumamoto, 8614193, Japan
	TEL	+81-96-351-8000
	E-mail	kodai-kawamura@saiseikaikumamoto.jp

Recruitment Status	COMPLETED

Date of First Enrollment		July. 05, 2012
Planned Number of Subjects		30
Nature of Investigation		Observational
Study Design	Description of Trial Design	prospective observational study
	Type of Control
	Trial Blinding Schema	open(masking not used)
	Randomized	No
Trial Phase		N/A
Key inclusion & exclusion criteria	Inclusion Criteria	1) Clinically confirmed acute exacerbation of fibrosing interstitial pneumonia patients in japan based on the JRS diagnostic criteria for acute exacerbation of interstitial pneumonia 2) Patients with written informed consent
	Exclusion Criteria	1) Patients with malignancy 2) Patients who have allergy symptoms for macrolide 3) Patient with long QT syndrome or ventricular tachycardia 4) Patients who are not appropriate to participate to the trial.
	Minimum Age	18age old over
	Maximum Age	No limit
	Sex of Participants	Both
Trial Indication(s)		acute exacerbation of fibrosing interstitial pneumonia
Intervention(s)		Intervention type:DRUG Name of intervention: Dose form / Japanese Medical Device Nomenclature:INJECTION Route of administration / Site of application:INTRAVENOUS DRIP Dose per administration:500 mg Dosing frequency / Frequency of use:QD for 3-5 days Planned duration of intervention: Intended dose regimen: detailes of teratment arms: Comparative intervention name: Dose form / Japanese Medical Device Nomenclature: Route of administration / Site of application: Dose per administration: Dosing frequency / Frequency of use: Planned duration of intervention: Intended dose regimen:
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		60-day survival from admission
Secondary Outcome(s)		safety of intravenous azithromycin for patients with acute exacerbation of fibrotic interstitial pneumonia

Primary Sponsor	Dividion of respiratory medicine, Saiseikai Kumamoto Hospital
Secondary Sponsor	none

Sources of funding	self funding

Name of Ethics Committee	Institutional Review Board
Address
TEL
FAX
E-Mail
Ethics Committee Website
Committee Approval Number
Approved by Ethics Committee	Yes
Reason for Unapproval

Date of approved	July. 04, 2012

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Secondary Study ID	JMA-IIA00095
Issuer Name

Countrie(s) of Recruitment	Japan

History of Changes

No	Publication date
2	July. 30, 2015	(this page)	Changes
1	Aug. 01, 2012	Detail

List of change history