UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053214 |
|---|---|
| Receipt number | R000060730 |
| Scientific Title | Multidrug -or Carbapenem-resistant Gram-negative Infections: Efficacy and Safety Assessment of Siderophore Cephalosporin Cefiderocol, Highlighting Infection-causative bacterial analysis in Japan -MUSASHI study- |
| Date of disclosure of the study information | 2023/12/25 |
| Last modified on | 2023/12/25 13:41:09 |
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Basic information
Public title
Multidrug -or Carbapenem-resistant Gram-negative Infections: Efficacy and Safety Assessment of Siderophore Cephalosporin Cefiderocol, Highlighting Infection-causative bacterial analysis in Japan -MUSASHI study-
Acronym
Multidrug -or Carbapenem-resistant Gram-negative Infections: Efficacy and Safety Assessment of Siderophore Cephalosporin Cefiderocol, Highlighting Infection-causative bacterial analysis in Japan -MUSASHI study-
Scientific Title
Multidrug -or Carbapenem-resistant Gram-negative Infections: Efficacy and Safety Assessment of Siderophore Cephalosporin Cefiderocol, Highlighting Infection-causative bacterial analysis in Japan -MUSASHI study-
Scientific Title:Acronym
Multidrug -or Carbapenem-resistant Gram-negative Infections: Efficacy and Safety Assessment of Siderophore Cephalosporin Cefiderocol, Highlighting Infection-causative bacterial analysis in Japan -MUSASHI study-
Region
| Japan |
Condition
Condition
Infections
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical safety and efficacy of cefiderocol in combination with micro bacterial characteristics
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Characteristics of patients treated with cefiderocol
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who participated in the post marketing survey of Cefidelocol
Patients who have obtained written consent to participate in the study
Key exclusion criteria
Patients who used cefidrocol for other indications than in the package insert
Patients who have received Cefidelocol for less than 72 hours
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shinzo |
| Middle name | |
| Last name | Hiroi |
Organization
Shionogi & Co., Ltd.
Division name
Medical Affairs Department
Zip code
541-0045
Address
1-8, Doshomachi 3-Chome, Chuo-ku, Osaka
TEL
+81-6-6202-2161
shinzo.hiroi@shionogi.co.jp
Public contact
Name of contact person
| 1st name | Ippei |
| Middle name | |
| Last name | Morita |
Organization
Shionogi & Co., Ltd.
Division name
Medical Affairs Department
Zip code
541-0045
Address
1-8, Doshomachi 3-Chome, Chuo-ku, Osaka
TEL
+81-6-6202-2161
Homepage URL
ippei.morita@shionogi.co.jp
Sponsor or person
Institute
Shionogi & Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Shionogi & Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation Heishinkai OPHAC Hospital ERC
Address
4-1-29 Miyahara, Yodogawa-ku, Osaka-shi, Osaka
Tel
+81-6-6395-9000
NA
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
| 2023 | Year | 12 | Month | 25 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 12 | Month | 26 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2023 | Year | 12 | Month | 25 | Day |
Last modified on
| 2023 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060730
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
