臨床研究等提出・公開システム

Date of registration	Dec. 14, 2011
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080221672

Scientific Title	Phase3 study of T-1220 in the patients with bacterial infectious disease-Open label, multi-center study-
Public Title

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	Open label, multi-center study
Study Design	Objective
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	(1)Sex:male or female (2)Age: 20 years and older for adult and 28 days to 16 years old (inclusive) for child (3)Outpatient or inpatient: inpatient (4)Presence of definite symptom/findings of infectious disease (5)Others
	Exclusion Criteria	(1)Medical history of allergy to any beta-lactam antibacterial agents. (2)Patient with infectious mononucleosis. (3)Pregnant females, females wishing to become pregnant or being possibly pregnant, and lactating females. (4)Others.
	Minimum Age	20age old over
	Maximum Age	15age old under
	Gender	Both
Health Condition or Problem Studied		Sepsis, Acute bronchitis, Pneumonia, Lung abscess, Pyothorax, Secondarinfection of chronic respiratory disease, Cystitis, Pyelonephritis, Cholecystitis, Cholangitis, Bartholinitis, Intrauterine infection, Uterine adnexitis, Parametritis, Purulent meningitisy
Intervention(s)		investigational material(s) Generic name etc : T-1220 INN of investigational material : Piperacillin Sodium Therapeutic category code : 613 Antibiotic preparations acting mainly on gram-positive, gram-negative bacteria Dosage and Administration for Investigational material : Intravenous drip
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Efficacy and safety Same as above
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-111714
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
13	Dec. 17, 2018	(this page)	Changes
12	Oct. 02, 2018	Detail	Changes
11	Oct. 02, 2018	Detail	Changes
10	Oct. 02, 2018	Detail	Changes
9	June. 26, 2017	Detail	Changes
8	July. 10, 2014	Detail	Changes
7	July. 10, 2014	Detail	Changes
6	Mar. 11, 2013	Detail	Changes
5	Mar. 11, 2013	Detail	Changes
4	Feb. 14, 2012	Detail	Changes
3	Feb. 14, 2012	Detail	Changes
2	Dec. 14, 2011	Detail	Changes
1	Dec. 14, 2011	Detail

List of change history