UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005046 |
|---|---|
| Receipt number | R000005936 |
| Scientific Title | Clinical trial-Efficacy and safety of biapenem in elderly respiratory tract infection- |
| Date of disclosure of the study information | 2011/02/15 |
| Last modified on | 2013/08/15 10:45:13 |
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Basic information
Public title
Clinical trial-Efficacy and safety of biapenem in elderly respiratory tract infection-
Acronym
Clinical trial-Efficacy and safety of biapenem in elderly respiratory tract infection-
Scientific Title
Clinical trial-Efficacy and safety of biapenem in elderly respiratory tract infection-
Scientific Title:Acronym
Clinical trial-Efficacy and safety of biapenem in elderly respiratory tract infection-
Region
| Japan |
Condition
Condition
elderly respiratory tract infection
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To verify the pharmacological efficacy and safety of biapenem in elderly over 65 years old respiratory tract infection
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1)Clinical effect of three days later from starting of administration
2)Body temperature,amount of sputum,
property of sputum,WBC,ESR,CRP of three days later from starting of administration
3)Total clinical effect of the analysis objects
4)Bacteriological effect of the analysis objects
5)The incidence of the side effects
6)Pharmacological assessment
Key secondary outcomes
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 elderly people over 65 years old
the case fulfilling all under points two days before from starting of administration
2 a body temperature higher than 37 degrees C
3 CRP higher than 1.0mg per dl
4 evidence of pneumonia in the chest radiography or chest CT
5 purulent sputum
Key exclusion criteria
1 under severe heart damage
under severe liver damage
under severe kidney damage
2 under many combination drug therapy
3 beta lactam agent allergy
4 pregnant female
5 atypical pneumonia
6 taking antiepileptic medications
7 others who evaluated as inappropriate by doctor in attendance
Target sample size
4
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | FumiKARINO |
Organization
Shimane University Faculty of Medicine
Division name
Oncology and Respiratory Medicine
Zip code
Address
89-1 Enya-cho Izumo Shimane 693-8501 JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Shimane University Faculty of Medicine
Division name
Oncology and Respiratory Medicine
Zip code
Address
TEL
080-1918-3100
Homepage URL
Sponsor or person
Institute
Shimane University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Shimane University Faculty of Medicine
Organization
Division
Category of Funding Organization
Other
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
| 2011 | Year | 02 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
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 | 09 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2013 | Year | 08 | Month | 15 | Day |
Other
Other related information
To verify the pharmacological efficacy and safety of biapenem in elderly over 65 years old respiratory tract infection
observation point
1)Clinical effect of three days later from starting of administration
2)Body temperature,amount of sputum,
property of sputum,WBC,ESR,CRP of three days later from starting of administration
3)Total clinical effect of the analysis object
4)Bacteriological effect of the analysis object
5)The incidence of the side effect
6)Pharmacological assessment
Management information
Registered date
| 2011 | Year | 02 | Month | 08 | Day |
Last modified on
| 2013 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005936
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
