UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009396 |
|---|---|
| Receipt number | R000011038 |
| Scientific Title | Efficacy of high dose doripenem on patients with severe infectious diseases in intensive care units |
| Date of disclosure of the study information | 2012/12/01 |
| Last modified on | 2017/06/15 10:09:26 |
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Basic information
Public title
Efficacy of high dose doripenem on patients with severe infectious diseases in intensive care units
Acronym
Efficacy of high dose doripenem on patients with severe infectious diseases in intensive care units
Scientific Title
Efficacy of high dose doripenem on patients with severe infectious diseases in intensive care units
Scientific Title:Acronym
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/µL or <4,000/µL, 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
| 1st name | |
| Middle name | |
| Last name | Kenichiro Fukuda |
Organization
Showa University school of medicine
Division name
Department of Emergency Medicine
Zip code
Address
1-5-8 Hatanodai Sinagawa-ku Tokyo Japan
TEL
03-3784-8000
kennyfukuda511@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichiro Fukuda |
Organization
Showa University school of medicine
Division name
Department of Emergency Medicine
Zip code
Address
1-5-8 Hatanodai Shinagawa-ku Tokyo 142-8555 Japan
TEL
03-3784-8000
Homepage URL
kennyfukuda511@yahoo.co.jp
Sponsor or person
Institute
Showa University school of medicine
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2011 | Year | 10 | Month | 25 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011038
