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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000006034
Receipt No. R000007145
Scientific Title Clinical trial-Efficacy and safety of TAZ/PIPC in elderly respiratory tract infection-NHCAP-
Date of disclosure of the study information 2011/07/27
Last modified on 2015/01/26

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Basic information
Public title Clinical trial-Efficacy and safety of TAZ/PIPC in elderly respiratory tract infection-NHCAP-
Acronym Clinical trial-Efficacy and safety of TAZ/PIPC in elderly respiratory tract infection-NHCAP-
Scientific Title Clinical trial-Efficacy and safety of TAZ/PIPC in elderly respiratory tract infection-NHCAP-
Scientific Title:Acronym Clinical trial-Efficacy and safety of TAZ/PIPC in elderly respiratory tract infection-NHCAP-
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 TAZ/PIPC(Tazobactam/piperacillin)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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
2 the case fulfilling any of under the points
-examined in long-term health facilities for recuperation, the treatment
-discharged within 180 days
-elderly or handicapped need care
-who have received endovascular treatment continued at the hospital (dialysis, antibiotics, anticancer, immunosuppressant therapy, etc.)
3 the case fulfilling all under points two days before from starting of administration
-a body temperature higher than 37 degrees C
-CRP higher than 1.0mg per dl
-evidence of pneumonia in the chest radiography or chest CT
Key exclusion criteria 1 under severe heart damage
under severe liver damage
under severe kidney damage
2 who is strongly suspected of atypical pneumonia
3 who must be used with non-macrolide antibiotics
4 beta lactam agent allergy
5 who evaluated as inappropriate by doctor in attendance
Target sample size 20

Research contact person
Last 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 0853-20-2580
Email fumi1224@med.shimane-u.ac.jp

Public contact
1st name of contact person
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 0853-20-2580
Homepage URL
Email fumi1224@med.shimane-u.ac.jp

Sponsor
Institute Shimane University Faculty of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Shimane University Faculty of Medicine
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
2011 Year 07 Month 27 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 Open public recruiting
Date of protocol fixation
2010 Year 12 Month 27 Day
Date of IRB
Anticipated trial start date
2010 Year 12 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 To verify the pharmacological efficacy and safety of TAZ/PIPC(Tazobactam/piperacillin)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 07 Month 25 Day
Last modified on
2015 Year 01 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007145


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