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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004408
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Hamamatsu University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005269

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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