臨床研究等提出・公開システム

Date of registration	Nov. 27, 2014
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080222672

Scientific Title	A Phase II, multi-center, randomized, double-blind study of T-4288 in patients with community-acquired pneumonia
Public Title	A Phase II study of T-4288 in patients with community-acquired pneumonia

Completion Date or Terminated date
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	FUJIFILM Toyama Chemical Co., Ltd.
	Address	https://www.fujifilm.co.jp/form/fftc/en/general/input.php?id=FFTCClinicalEn
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size
Study Type		Interventional
Study Design	Study Design	Multi-center, Randomized, Double-Blind, Active-controlled study
Study Design	Objective
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	1. Age: 20 years of age and older 2. Gender : Both 3. Confirmed clear infiltrative shadow by chest X-ray or CT within 48 hours prior to the first administration of the study drug 4. Confirmed at least one of the following changes in laboratory values; -WBC increased (WBC > 10000 /mm3) -Stab cell > 15% -WBC decreased (WBC < 4500 /mm3) 5. Confirmed at least one of the following clinical symptoms and/or findings: -Cough -Abnormal findings on auscultation and/or percussion -Dyspnea or tachypnea -Hypoxemia 6. Others
	Exclusion Criteria	1. Having improvement of clinical symptoms due to pneumonia by other systemic antibiotics 2. Having a history of allergy to macrolide or quinolone antibiotics 3. Others
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Community-acquired pneumonia
Intervention(s)		investigational material(s) Generic name etc : T-4288 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 : Levofloxacin INN of investigational material : Levofloxacin Therapeutic category code : 624 Synthetic antibacterials 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		efficacy, safety and pharmacokinetic profile
Secondary Outcome

Primary Sponsor	Toyama Chemical Co., Ltd.(Current FUJIFILM Toyama Chemical Co., Ltd.)
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name of IRB
Address of IRB
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review
Date of Approval by IRB

Secondary ID No.	JapicCTI-142723
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
7	Dec. 17, 2018	(this page)	Changes
6	Oct. 02, 2018	Detail	Changes
5	Oct. 02, 2018	Detail	Changes
4	Jan. 11, 2017	Detail	Changes
3	Jan. 11, 2017	Detail	Changes
2	Nov. 27, 2014	Detail	Changes
1	Nov. 27, 2014	Detail

List of change history