UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003964 |
|---|---|
| Receipt number | R000004765 |
| Scientific Title | Clinical evaluation of Biapenem 0.3g, three times daily dosing in eldery patients with pneumonia (moderate and severe infection) |
| Date of disclosure of the study information | 2010/07/29 |
| Last modified on | 2014/02/03 14:41:03 |
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Basic information
Public title
Clinical evaluation of Biapenem 0.3g, three times daily dosing in eldery patients with pneumonia (moderate and severe infection)
Acronym
Clinical evaluation of Biapenem 0.3g three times daily dosing
Scientific Title
Clinical evaluation of Biapenem 0.3g, three times daily dosing in eldery patients with pneumonia (moderate and severe infection)
Scientific Title:Acronym
Clinical evaluation of Biapenem 0.3g three times daily dosing
Region
| Japan |
Condition
Condition
Moderate and severe pneumonia
Classification by specialty
| Pneumology | Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate clinical response and safety of Biapenem at doses of 0.3g three times daily in eldery patients with pneumonia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation of clinical response after 3 days administration, clinical response at the end of treatment, bacteriological response, serum concentration measurement and PK-PD analysis
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
Elderly patients (50 cases) aged 65 and over with moderate and severe pneumonia, treated with Biapenem 0.3g three times daily for less than 2 weeks during the period of July 2010 to May 2011
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
Elderly patients aged 65 and over regardless of underlying disease. Severity levels of pneumonia are classified by the severity criteria according to "Guidelines for the management of respiratory infections, 2008" edited by The Japanese Respiratory Society.
Key exclusion criteria
(1)Cases with severe cardiac, hepatic, renal function disorder(2)Cases with a history of allergy to B-lactam antibiotics(carbapenems,cephems,penicillins,etc.)(3)Cases which therapeutic response of B-lactam antibiotics can't be expected(caused by virus,mycoplasma,chlamydia and fungus)(4)Cases treated with sodium valproate(5)Cases with improvement by previous treatment of antimicrobial agent(6)Cases with similar infectious episode of ineffective treatment with carbapenem antibiotics(7)Other cases which doctor in charge regard inadequate to include in the study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitake Sato |
Organization
Fuji Heavy Industries Ltd Health Insurance Society Ota Hospital
Division name
Pediatrics
Zip code
Address
Hachiman-cho29-5,Ota-shi,Gunma-ken
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsuru Sando |
Organization
Fuji Heavy Industries Ltd Health Insurance Society Ota Hospital
Division name
Pharmaceutical Department
Zip code
Address
Hachiman-cho29-5,Ota-shi,Gunma-ken
TEL
Homepage URL
Sponsor or person
Institute
Fuji Heavy Industries Ltd Health Insurance Society Ota Hospital: Neurology, Ashikaga Red Cross Hospital :Respiratory internal medicine
Institute
Department
Personal name
Funding Source
Organization
Keio University Faculty of Medicine Keio University Hospital
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
| 2010 | Year | 07 | Month | 29 | 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 | 04 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | 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
Management information
Registered date
| 2010 | Year | 07 | Month | 28 | Day |
Last modified on
| 2014 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004765
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
