臨床研究等提出・公開システム

Japanese

Date of registration	Oct. 14, 2014
Last modified on	July. 09, 2018
Trial ID	jRCT1090220197

Scientific Title	Nation-wide surveillance of invasive pneumococcal infection in adults
Public Title	Nation-wide surveillance of invasive pneumococcal infection in adults

Study end date	Dec. 31, 2016
Performed Number of Subjects
Baseline Characteristics
Participant Flow
Safety Conclusions
Efficacy Conclusions
Discussion and Overall Conclusions
Posted Date
Date of First Publication
Results Links

Plan to Share IPD
Plan Description
Protocol Links

Contact for Scientific Queries	Investigator Name	Takaya Maruyama
	Investigator Organization	National hospital Organization Mie National Hospital
	Address	357 Ohzatokubota, Tsu, Mie Japan 514-0125
	TEL	+81-59-232-2531
	E-mail	maruyamat@mie-m.hosp.go.jp
Contact for Public Queries	Contact Name	Takaya Maruyama
	Contact Organization	National hospital Organization Mie National Hospital
	Address	357 Ohzatokubota, Tsu, Mie Japan 514-0125
	TEL	+81-59-232-2531
	E-mail	maruyamat@mie-m.hosp.go.jp

Recruitment Status	COMPLETED

Date of First Enrollment		Jan. 01, 2013
Planned Number of Subjects		800
Nature of Investigation		Observational
Study Design	Description of Trial Design	A prospective multicenter cohort study
	Type of Control
	Trial Blinding Schema	open(masking not used)
	Randomized	No
Trial Phase		N/A
Key inclusion & exclusion criteria	Inclusion Criteria	Patients with IPD 1) S. pneumoniae is isolated from physiologically sterile site [spinal fluid, blood, etc]. 2)Diagnosed as bacterial meningitis, bacteremia, bacteremic pneumonia, arthritis, peritonitis
	Exclusion Criteria	Patients with IPD 1) S. pneumoniae is not isolated from sterile site . 2)Not diagnosed as bacterial meningitis, bacteremia, bacteremic pneumonia, arthritis, peritonitis
	Minimum Age	15age old over
	Maximum Age	No limit
	Sex of Participants	Both
Trial Indication(s)		Invasive pneumococcal disease
Intervention(s)		Intervention type: Name of intervention: 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: 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)		To analyze the serotype distribution, drug sensitivity and genotypes of S.pneumoniae isolated from adult patients with IPD 2)To evaluate outcome, risk factors of drug resistance and prognostic factors in the patients with IPD
Secondary Outcome(s)

Primary Sponsor	Takaya Maruyama, Department of respiratory medicine, National hospital Organization Mie National Hospital
Secondary Sponsor	National hospital Organization Tokyo National Hospital, National hospital Organization Hokkaido Medical Center, Keio University, Kyoto University, Nagasaki University

Sources of funding	(Pfizer Japan Inc

Name of Ethics Committee	Institutional review board in National Hospital Organization Mie National Hospital
Address
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Ethics Committee Website
Committee Approval Number
Approved by Ethics Committee	Yes
Reason for Unapproval

Date of approved	Sept. 12, 2012

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Secondary Study ID	JMA-IIA00197
Issuer Name

Countrie(s) of Recruitment	Japan

History of Changes

No	Publication date
2	July. 09, 2018	(this page)	Changes
1	Oct. 14, 2014	Detail

List of change history