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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005104
Receipt No. R000006068
Scientific Title Annual changes of pathogen and antimicrobial susceptibility of causative bacteria isolated from patient with cholecystitis, cholangitis, severe acute pancreatitis
Date of disclosure of the study information 2011/02/18
Last modified on 2013/10/10

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Basic information
Public title Annual changes of pathogen and antimicrobial susceptibility of causative bacteria isolated from patient with cholecystitis, cholangitis, severe acute pancreatitis
Acronym Annual changes of pathogen and antimicrobial susceptibility of causative bacteria isolated from patient with cholecystitis, cholangitis, severe acute pancreatitis
Scientific Title Annual changes of pathogen and antimicrobial susceptibility of causative bacteria isolated from patient with cholecystitis, cholangitis, severe acute pancreatitis
Scientific Title:Acronym Annual changes of pathogen and antimicrobial susceptibility of causative bacteria isolated from patient with cholecystitis, cholangitis, severe acute pancreatitis
Region
Japan

Condition
Condition Cholecystitis, Cholangitis, severe Acute pancreatitis
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate changes of antimicrobial susceptibility and bacteria in biliary infection and severe acute pancreatitis

And to evaluate clinical response and safety of Biapenem
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Causative bacteria and antimicrobial susceptibility before and after antimicrobial administration

Clinical response and safety of day 3 and day 7 after Biapenem is administered
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization 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 Maneuver
Interventions/Control_1 Choler, Blood culture
Administration of antibiotic
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Inpatient aged 20 or over regardless of gender
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 pregnant, lactating or suspected of being pregnant
(4) Cases which therapeutic response of B-lactam antibiotics can not be expected (caused by virus, mycoplasma, chlamydia and fungus)
(5) Cases treated with sodium valproate or with central nervous system damage such as epilepsia
(6) Cases which need combined usage of diuretic such as furosemide
(7) Cases with improvement by previous treatment of antimicrobial agent
(8) Cases with similar infectious episode of ineffective treatment with carbapenem antibiotics
(9) 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 Shoji Watanabe
Organization Nagaoka Chuo Hospital Koseiren,
Niigata-Ken
Division name internal medicine
Zip code
Address 2041 Kawasaki-machi,Nagaoka-Shi,Niigata-Ken
TEL 0258-35-3700
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shoji Watanabe
Organization Nagaoka Chuo Hospital Koseiren,Niigata-Ken
Division name internal medicine
Zip code
Address 2041 Kawasaki-machi,Nagaoka-Shi,Niigata-Ken
TEL 0258-35-3700
Homepage URL
Email shownabe@nagachu.jp

Sponsor
Institute Nagaoka Chuo Hospital Koseiren,
Niigata-Ken
Institute
Department

Funding Source
Organization None
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 02 Month 18 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
2010 Year 12 Month 13 Day
Date of IRB
Anticipated trial start date
2011 Year 01 Month 01 Day
Last follow-up date
2011 Year 12 Month 01 Day
Date of closure to data entry
2012 Year 03 Month 01 Day
Date trial data considered complete
2013 Year 10 Month 10 Day
Date analysis concluded
2013 Year 11 Month 30 Day

Other
Other related information

Management information
Registered date
2011 Year 02 Month 18 Day
Last modified on
2013 Year 10 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006068

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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