臨床研究等提出・公開システム

Date of registration	Oct. 16, 2019
Last modified on	Aug. 09, 2023
Trial ID	jRCT2080224917

Scientific Title	A Phase 3, Multicenter, Randomized, Double-Blind Noninferiority Study of Oral Solithromycin Compared to Oral Azithromycin in the Treatment of Patients with Community-Acquired Pneumonia
Public Title	Efficacy and safety of oral solithromycin versus oral azithromycin in the treatment of community-acquired pneumonia

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	FUJIFILM Toyama Chemical Co., Ltd
	Address
	Phone Number
	E-mail Address	https://www.fujifilm.com/fftc/ja/form/FFTC-Clinical

Contact for Public Queries	Name
	Contact Name for Public Queries	FUJIFILM Toyama Chemical Co., Ltd.
	Address
	Phone Number
	E-mail Address	https://www.fujifilm.com/fftc/ja/form/FFTC-Clinical

Recruitment Status	completed

Date of First Enrolment		Oct. 25, 2019
Target Sample Size		506
Study Type		Interventional
Study Design	Study Design	Multicenter, Stratified Randomized, Double-Blind Study
Study Design	Objective	treatment purpose
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	1. Age: 18 years or older (at the time of obtaining informed consent) 2. Sex : Irrespective 3. Outpatient/hospitalization: Irrespective 4. Patients with no history of hospitalization within 2 weeks before the development of pneumonia, or no history of hospitalization in a long-term care institution 5. Patients with newly developed infiltrative shadow on either chest X-ray imaging or computed tomography (CT) imaging taken within 48 hours before the start of study drug administration 6. Patients from whom written informed consent can be obtained from the patients themselves 7. Others
	Exclusion Criteria	1. Patients with symptoms which are showing improvement by having received systemic oral antibacterial drugs 2. Patients with a history of allergy to macrolides or ketolides 3. Others
	Minimum Age	18age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Community-acquired pneumonia
Intervention(s)		investigational material(s) Generic name etc : Solithromycin INN of investigational material : Solithromycin Therapeutic category code : 614 Antibiotic preparations acting mainly on gram-positive bacteria and mycoplasma Dosage and Administration for Investigational material : Oral Multiple Dose control material(s) Generic name etc : Azithromycin INN of investigational material : Azithromycin Therapeutic category code : 614 Antibiotic preparations acting mainly on gram-positive bacteria and mycoplasma Dosage and Administration for Investigational material : Oral Multiple Dose
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Clinical response at TOC
Secondary Outcome		Clinical response at Day 4 and Day 8 Microbiological response at Day 4, Day 8 and TOC

Primary Sponsor	FUJIFILM Toyama Chemical Co., Ltd.
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name of IRB	Japanese Red Cross Nagasaki Genbaku Isahaya Hospital Institutional Review Board
Address of IRB	986-2, Taramicho Keya, Isahaya, Nagasaki, 859-0497, Japan
Phone Number of IRB	+81-957-43-2111
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	Sept. 13, 2019

Secondary ID No.	JapicCTI-195002
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
6	Aug. 09, 2023	(this page)	Changes
5	Jan. 16, 2023	Detail	Changes
4	Aug. 04, 2022	Detail	Changes
3	Aug. 03, 2022	Detail	Changes
2	Nov. 09, 2021	Detail	Changes
1	Oct. 24, 2019	Detail

List of change history