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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003964
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Fuji Heavy Industries Ltd Health Insurance Society Ota Hospital: Neurology, Ashikaga Red Cross Hospital :Respiratory internal medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004765

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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