UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028155 |
|---|---|
| Receipt number | R000032225 |
| Scientific Title | The effectiveness of de-escalation to cefmetazole for bacteremia. Open-label randomized non-inferiority trial |
| Date of disclosure of the study information | 2017/07/10 |
| Last modified on | 2017/07/10 09:40:14 |
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Basic information
Public title
The effectiveness of de-escalation to cefmetazole for bacteremia. Open-label randomized non-inferiority trial
Acronym
De-escalation to cefmetazole
Scientific Title
The effectiveness of de-escalation to cefmetazole for bacteremia. Open-label randomized non-inferiority trial
Scientific Title:Acronym
De-escalation to cefmetazole
Region
| Japan |
Condition
Condition
bacteremia
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Cefmetazole, a cefamycin has activity against ESBL producing bacteria and preceding retrospective studies demonstrated its efficacy. It is a promising agent to spare carbapenems. However, there is no prospective studies to confirm its efficacy and safety. The current study examines the effectiveness of cefmetazole as an de-escalating agent for those with bacteremia diagnosed by blood cultures, comparing with those without de-escalation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Mortality at 30 days after entry.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
de-escalation to cefmetazole 1g every 6-8 hours for about 10-14 days, depending on renal function of the patients.
Interventions/Control_2
Continues current treatment for about 10-14 days, depending on renal function of the patients.
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
Bacteremic patients diagnosed by blood cultures, and those who were judged to be eligible for de-escalation to cefmetazole by infectious diseases doctors.
Key exclusion criteria
When the patient or the physician treating did not consent to the study participation. Those who had or are likely to have significant past history of cefmetazole side effects, such as anaphylaxis by beta-lactams.
Target sample size
184
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kentaro Iwata |
Organization
Kobe University
Division name
Division of Infectious Diseases
Zip code
Address
Kusunokicho 7-5-2, Chuoku, Kobe
TEL
078-382-6297
kentaroiwata1969@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toko Nakata |
Organization
Kobe University
Division name
Division of Infectious Diseases
Zip code
Address
Kusunokicho 7-5-2, Chuoku, Kobe
TEL
078-382-6297
Homepage URL
kobeid@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
self funding
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
| 2017 | Year | 07 | Month | 10 | 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
| 2017 | Year | 07 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 10 | Day |
Last modified on
| 2017 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032225
| 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 |
