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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006538
Receipt No. R000007717
Scientific Title Efficacy of using antimicrobials based on PK/PD principle in the treatment of NHCAP
Date of disclosure of the study information 2011/10/14
Last modified on 2012/11/19

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Basic information
Public title Efficacy of using antimicrobials based on PK/PD principle in the treatment of
NHCAP
Acronym Efficacy of using antimicrobials based on PK/PD principle in the treatment of
NHCAP
Scientific Title Efficacy of using antimicrobials based on PK/PD principle in the treatment of
NHCAP
Scientific Title:Acronym Efficacy of using antimicrobials based on PK/PD principle in the treatment of
NHCAP
Region
Japan

Condition
Condition NHCAP(HCAP)
Classification by specialty
Pneumology Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Efficacy of using antimicrobials based on PK/PD in NHCAP patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Duration of hospitalization
Key secondary outcomes Mortality in hospital
Clinical effect, days 4 and 7

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Group A:using SBT/ABPC 1.5g q6hr
Interventions/Control_2 Group B:using SBT/ABPC 3.0g q12hr
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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Healthcare associated pneumonia (HCAP)
Patients who satisfy the criteria at least one item of each of A,B and C

A:1 fever(BT>37.0)
2 cough
3 hypoxemia
B:
1 Increased white blood cell count (WBC>10000/mm3), stab cells>15%, or decreased white blood cell count (WBC<4500/mm3)
2 Positive CRP
3 X-ray examination or CT scan of the chest reveal new infiltrative shadows

C:Patients who were admitted to nursing homes, care/rehabilitation facilities or health/care facilities for recuperation (for more than 48 hours) ,or who were hospitalized for more than two days for the past 90 days
Key exclusion criteria 1 Patients with renal dysfunction ( Ccr<10ml/min )
2 Immunocompromised patients or patients receiving immunosuppressive agents
3 Patients whose pneumonia could not be treated by SBT/ABPC
4 Patients with hypersensitivity to SBT/ABPC
5 Patients who were not considered as participant by attending physician
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nishio Kazumi
Organization Kawasaki Municipal Ida Hospital
Division name Department of Respiratory Medicine
Zip code
Address 2-27-1,ida,Nakahara,Kawasaki,210-0035,Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kawasaki Municipal Ida Hospital
Division name Department of Respiratory Medicine
Zip code
Address
TEL
Homepage URL
Email 83idasyo@city.kawasaki.jp

Sponsor
Institute Kawasaki Municipal Ida Hospital
Institute
Department

Funding Source
Organization Kawasaki Municipal Ida Hospital
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 10 Month 14 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
2011 Year 10 Month 07 Day
Date of IRB
Anticipated trial start date
2011 Year 10 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
2011 Year 10 Month 13 Day
Last modified on
2012 Year 11 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007717

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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