UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of high dose doripenem on patients with severe infectious diseases in intensive care units
Title of the study (Brief title)	Efficacy of high dose doripenem on patients with severe infectious diseases in intensive care units
Region	Japan

Condition
Condition	severe infectious diseases(pneumonia, bacteremia, etc)
Classification by specialty	Emergency medicine Intensive care medicine
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	Efficacy of high dose doripenem on patients with severe infectious diseases in intensive care units
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	clinical outcomes on the day of the final dosing
Key secondary outcomes	1)clinical outcomes on the third and the seventh day 2)duration of dosing 3)bacteriological efficacy after the final dosing 4)adverse effects and clinical examinations

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Infectious diseases with at least over two below items, including over 15 of APACHE II score (Vital signs) 1) fever >38C or hypothermia <36C 2) heart rate >90/min 3) respiratory rate >20/min or PaCO2 <32mmHG 4) WBC >12,000/&micro;L or <4,000/&micro;L, or over 10% in stab cells with the shift to left in neutrophil
Key exclusion criteria	1) more less than 16-old years 2) patients who have shown hypersensitivity to any component of beta lactams 3) non-infectious patients with fever 4) patients with causative isolates with no susceptibility to study drug (ex.MRSA, S.maltophila etc.), including metalo-beta-lactamase producing organisms 5) patients in treatment with valproic acid or with seizures and other CNS adverse experiences 6) physician's decision for adequateness in this study
Target sample size	20

Research contact person
Name of lead principal investigator	Kenichiro Fukuda
Organization	Showa University school of medicine
Division name	Department of Emergency Medicine
Address	1-5-8 Hatanodai Sinagawa-ku Tokyo Japan
TEL	03-3784-8000
Email	kennyfukuda511@yahoo.co.jp

Public contact
Name of contact person	Kenichiro Fukuda
Organization	Showa University school of medicine
Division name	Department of Emergency Medicine
Address	1-5-8 Hatanodai Shinagawa-ku Tokyo 142-8555 Japan
TEL	03-3784-8000
Homepage URL
Email	kennyfukuda511@yahoo.co.jp

Sponsor
Institute	Showa University school of medicine
Institute
Department

Funding Source
Organization	none
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	2012 Year 12 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2011 Year 10 Month 25 Day
Anticipated trial start date	2011 Year 11 Month 01 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	1) clinical outcomes on the third and the seventh days after the final dosing 2) duration of dosing 3) bacteriological efficacy after the final dosing 4) adverse effects and clinical examinations

Management information
Registered date	2012 Year 11 Month 26 Day
Last modified on	2017 Year 06 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011038