UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005104 |
|---|---|
| Receipt number | 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 10:38:18 |
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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
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
shownabe@nagachu.jp
Sponsor or person
Institute
Nagaoka Chuo Hospital Koseiren,
Niigata-Ken
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006068
