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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017219
Receipt No. R000018922
Scientific Title Feasibility and efficacy of the de-escalation therapy by Biapenem for postoperative bacterial pneumonia.
Date of disclosure of the study information 2015/04/22
Last modified on 2015/04/21

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Basic information
Public title Feasibility and efficacy of the de-escalation therapy by Biapenem for postoperative bacterial pneumonia.
Acronym Feasibility and efficacy of the de-escalation therapy by Biapenem for postoperative bacterial pneumonia.
Scientific Title Feasibility and efficacy of the de-escalation therapy by Biapenem for postoperative bacterial pneumonia.
Scientific Title:Acronym Feasibility and efficacy of the de-escalation therapy by Biapenem for postoperative bacterial pneumonia.
Region
Japan

Condition
Condition postoperative pneumonia after esophagectomy for esophageal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the feasibility and efficacy of the de-escalation therapy for postoperative pneumonia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Days required for the treatment of Biapenem
Postoperative hospital stay
Key secondary outcomes Clinical and bacteriological efficacy rates at each time point during the use of Biapanem.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Intravenous administration of Biapenem 300mg every six hours for the patient of postoperative pneumonia after esophagectomy
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
85 years-old >=
Gender Male and Female
Key inclusion criteria Canditates for esophagectomy in the University of Tokyo Hospital are pre-registered as candidates of this study. No exclusion criteria for the reconstruction methods.
Well informed and written convent.
Patients with the written informed concent are registered when diagnosed as postoperative pneumonia within 14 days after the operation along with the standard diagnostic criteria.
Key exclusion criteria Other infectious disease including SSI is present.
History of hyper reactive events caused by carbapenem.
The suspected pathogenic microbes of the pneumonia is; MRSA, MDRP, virus, mycoplasma, regionera, clmamigia, MAC, yeast.
MRSA or MDRP is present in any culture specimen during the in hospital course.
History of epilepsy or barproic acid use.
Renal disease with Ccr lower than 20ml/kg.min or requiring hemodialysis.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichi Yagi
Organization The University of Tokyo Hospital
Division name Department of Gastrointestinal Surgery
Zip code
Address 7-3-1 Hongo Bunkyo-ku, Tokyo, Japan
TEL 03-3815-5411
Email Yagik-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koichi Yagi
Organization The University of Tokyo Hospital
Division name Department of Gastrointestinal Surgery
Zip code
Address 7-3-1 Hongo Bunkyo ku, Tokyo, Japan
TEL 03-3815-5411
Homepage URL
Email Yagik-tky@umin.ac.jp

Sponsor
Institute Department of Gastrointestinal Surgery, The University of Tokyo Hospital
Institute
Department

Funding Source
Organization Department of Gastrointestinal Surgery
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 東京大学医学部附属病院(東京都)

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 22 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
2013 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 11 Month 01 Day
Last follow-up date
2016 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 04 Month 21 Day
Last modified on
2015 Year 04 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018922

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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