UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of doripenem (3g/day) in the treatment of severe/refractory respiratory infections
Title of the study (Brief title)	Efficacy and safety of doripenem (3g/day) in the treatment of severe/refractory respiratory infections
Region	Japan

Condition
Condition	severe/refractory respiratory infections
Classification by specialty	Pneumology Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of efficacy and safety of doripenem (3g/day) in the treatment in patients with severe/refractory respiratory infections.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Clinical efficacy at the end of doripenem (3g/day) administration
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Doripenem (3g/day) is given intravenously
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Patients 20 years of age and older 2.Patients with severe/very severe pneumonia according to the Japan Respiratory Society Guidelines for the Management of Community-Acquired Pneumonia or Healthcare-associated Pneumonia in Adults .
Key exclusion criteria	1.Patients who had been treated with doripenem 2.Contraindication for doripenem 3.Liver insufficiency (elevated levels of AST/ALT more than 5 times of the upper limits) 4.Renal insufficiency (elevated levels of BUN/creatinine more than 2 times of the upper limits) 5.Patients anticipating being susceptive of convulsion after brain disorders 6.Patients deemed ineligible by the attending physicians for various reasons.
Target sample size	50

Research contact person
Name of lead principal investigator	Toshinori Kawanami
Organization	University of Occupational and Environmental Health, Japan
Division name	Department of Respiratory Medicine
Address	1-1, Iseigaoka, Yahata-nishi-ku, Kitakyushu, Fukuoka, 807-8555, Japan
TEL	093-603-1611
Email	namihei@med.uoeh-u.ac.jp

Public contact
Name of contact person	Toshinori Kawanami
Organization	University of Occupational and Environmental Health, Japan
Division name	Department of Respiratory Medicine
Address	1-1, Iseigaoka, Yahata-nishi-ku, Kitakyushu, Fukuoka, 807-8555, Japan
TEL	093-603-1611
Homepage URL
Email	namihei@med.uoeh-u.ac.jp

Sponsor
Institute	Department of Respiratory Medicine, University of Occupational and Environmental Health, Japan
Institute
Department

Funding Source
Organization	Department of Respiratory Medicine, University of Occupational and Environmental Health, Japan
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2013 Year 12 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 10 Month 16 Day
Anticipated trial start date	2013 Year 10 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 12 Month 25 Day
Last modified on	2016 Year 10 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014820