UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012685 |
|---|---|
| Receipt number | R000014820 |
| Scientific Title | Efficacy and safety of doripenem (3g/day) in the treatment of severe/refractory respiratory infections |
| Date of disclosure of the study information | 2013/12/25 |
| Last modified on | 2016/10/04 15:11:06 |
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Basic information
Public title
Efficacy and safety of doripenem (3g/day) in the treatment of severe/refractory respiratory infections
Acronym
Efficacy and safety of doripenem (3g/day) in the treatment of severe/refractory respiratory infections
Scientific Title
Efficacy and safety of doripenem (3g/day) in the treatment of severe/refractory respiratory infections
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Toshinori Kawanami |
Organization
University of Occupational and Environmental Health, Japan
Division name
Department of Respiratory Medicine
Zip code
Address
1-1, Iseigaoka, Yahata-nishi-ku, Kitakyushu, Fukuoka, 807-8555, Japan
TEL
093-603-1611
namihei@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshinori Kawanami |
Organization
University of Occupational and Environmental Health, Japan
Division name
Department of Respiratory Medicine
Zip code
Address
1-1, Iseigaoka, Yahata-nishi-ku, Kitakyushu, Fukuoka, 807-8555, Japan
TEL
093-603-1611
Homepage URL
namihei@med.uoeh-u.ac.jp
Sponsor or person
Institute
Department of Respiratory Medicine, University of Occupational and Environmental Health, Japan
Institute
Department
Personal name
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)
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
| 2013 | Year | 12 | Month | 25 | 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
| 2013 | Year | 10 | Month | 16 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014820
