UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004408 |
|---|---|
| Receipt number | R000005269 |
| Scientific Title | Examination of the efficacy and safety of Doripenem for hospital-aquired pneumonia |
| Date of disclosure of the study information | 2010/11/01 |
| Last modified on | 2012/01/06 08:10:53 |
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Basic information
Public title
Examination of the efficacy and safety of Doripenem for hospital-aquired pneumonia
Acronym
Examination of the efficacy and safety of Doripenem
Scientific Title
Examination of the efficacy and safety of Doripenem for hospital-aquired pneumonia
Scientific Title:Acronym
Examination of the efficacy and safety of Doripenem
Region
| Japan |
Condition
Condition
Hospital-acquired pneumonia patient
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy and safety Doripenem for hospital-acqired pneumonia.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Clinical effectiveness
Key secondary outcomes
safety profile, PK
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
we treat with 0.5g of Doripenem for an hour or more and it is intravenous dripped three times a day. If the improvement is obtained, the antibiotics administering is ended. If the improvement is not obtained, the antibiotics is probably changed.
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
It is assumed that it meets all the following requirements.
1:written informed-consent.
2:age above 15 years
3:In-patient
4:Patient who needs antibiotics injection
5:serum Creatinin is 2.0mg/dl or less
6:It is a classification by the adult hospital acqired pneumonia diagnosis and treatment guideline and it is a patient with hospital acqired pneumonia,classified as the middle syndrome group (B group) and the serious illness group (C group)
Key exclusion criteria
The patient who corresponds to either the following excludes it from the object of the examination
1:Patient who is administering valproate sodium
2:Patient who has the past of shock or hypersensitivity for this medicine
3:Patient with liver dysfunction
AST(GOT):100IU/L or more, ALT(GTP):100IU/L or more
4:Patient who has disease of central nervous system or with the past of epilepsy
5:Patient who has allergy or serious side effect in betalactam system medicine
6:Patient who has been put in to examination once
7:Patient who participated in other clinical trials and clinical researches within four months in the past
8:Patient who needs using prohibition medicine
9:patient whom conducting of the examination doctor judged that pursuit of right evaluation and enough passage is impossible
10:Pediatrics
11:Patient who corresponds to PS4
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kingo Chida |
Organization
Hamamatsu University
Division name
Second division,Department
Zip code
Address
1-20-1,Handayama,Higashiku,Hamamatsu,Shizuoka,433-8112,Japan
TEL
053-35-2263
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Hamamatsu University
Division name
Clinical Pharmacology and Therapeutics
Zip code
Address
1-20-1,Handayama,Higashiku,Hamamatsu,Shizuoka,433-8112,Japan
TEL
Homepage URL
Sponsor or person
Institute
Hamamatsu University
Institute
Department
Personal name
Funding Source
Organization
No
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
| 2010 | Year | 11 | 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
Completed
Date of protocol fixation
| 2010 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 01 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 10 | Month | 19 | Day |
Last modified on
| 2012 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005269
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| Registered date | File name |
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| Registered date | File name |
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