UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017219 |
|---|---|
| Receipt number | 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 18:56:40 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
Yagik-tky@umin.ac.jp
Sponsor or person
Institute
Department of Gastrointestinal Surgery, The University of Tokyo Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018922
