UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058651 |
|---|---|
| Receipt number | R000067073 |
| Scientific Title | Comparison Efficacy of Cefmetazole or Flomoxef Versus Carbapenem Antibiotics for ESBL-Producing Enterobacterales Bacteremia: A Systematic Review and Meta-Analysis |
| Date of disclosure of the study information | 2025/07/31 |
| Last modified on | 2025/07/31 09:02:02 |
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Basic information
Public title
Comparison Efficacy of Cefmetazole or Flomoxef Versus Carbapenem Antibiotics for ESBL-Producing Enterobacterales Bacteremia: A Systematic Review and Meta-Analysis
Acronym
Comparison Efficacy of Cefmetazole or Flomoxef Versus Carbapenem Antibiotics for ESBL-Producing Enterobacterales Bacteremia: A Systematic Review and Meta-Analysis
Scientific Title
Comparison Efficacy of Cefmetazole or Flomoxef Versus Carbapenem Antibiotics for ESBL-Producing Enterobacterales Bacteremia: A Systematic Review and Meta-Analysis
Scientific Title:Acronym
Comparison Efficacy of Cefmetazole or Flomoxef Versus Carbapenem Antibiotics for ESBL-Producing Enterobacterales Bacteremia: A Systematic Review and Meta-Analysis
Region
| Japan |
Condition
Condition
Extended-spectrum beta-lactamase (ESBL)-producing Enterobacterales bacteremia
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In recent years, the number of infections caused by antimicrobial-resistant organisms have been increasing worldwide, and the number of associated deaths continues to rise annually. Treatment and infection control strategy for antimicrobial-resistant organisms is a significant public health concern. Extended-spectrum beta-lactamase (ESBL)-producing Enterobacterales represent one of major global health problem as an antimicrobial-resistant organisms. Carbapenems is the standard treatment for these organisms infections, and there is little evidence supporting the use of alternative antimicrobial agents.
Cefmetazole and flomoxef belong to cephamycin-class antibiotics that are especially-available in Asian countries, including Japan. These agents have shown potential efficacy against bloodstream infections caused by ESBL-producing Enterobacterales, and accumulating evidence from Asia suggests their clinical utility. However, there was no randomized controlled trials, and high-quality evidence remains insufficient to support their results.
Therefore, we conducted a systematic review and meta-analysis to evaluate the efficacy of cefmetazole and flomoxef compared with carbapenems, against bloodstream infections caused by ESBL-producing Enterobacterales.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
14 or 30 day-mortality rates
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
We will conduct a literature search to compare 14 day or 30 day mortality, between cefmetazole or flomoxef and carbapenems for patients with ESBL-producing Enterobacterales bacteremia. Our search will be performed in the following databases: PubMed, Japanese Journal of Chemotherapy, Japanese Journal of Infection Prevention and Control, Ichushi-WEB, Cochrane Review, CINAHL, and Web of Science.
Key exclusion criteria
Under 18 years old,Pregnancy,Infections caused by ESBL producing Enterobacteriaceae without bacteremia,No information about 14 day or 30 day mortality,Studies for which the full text was not accessible
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Haruka |
| Middle name | |
| Last name | Imai |
Organization
Tohoku Medical and Pharmaceutical University and Tohoku Medical and Pharmaceutical University Hospital
Division name
Division of Infectious Diseases and Infection Control, Faculty of Medicine, and Division of Infectious Diseases and Department of Infection Prevention and Control
Zip code
983-8512
Address
1-12-1, Fukumuro, Miyagino-ku, Sendai, Miyagi, Japan
TEL
0222591221
m05009hi@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Haruka |
| Middle name | |
| Last name | Imai |
Organization
Tohoku Medical and Pharmaceutical University and Tohoku Medical and Pharmaceutical University Hospit
Division name
Division of Infectious Diseases and Infection Control, Faculty of Medicine
Zip code
9838512
Address
1-12-1, Fukumuro, Miyagino-ku, Sendai, Miyagi, Japan
TEL
0222591221
Homepage URL
m05009hi@jichi.ac.jp
Sponsor or person
Institute
Tohoku Medical and Pharmaceutical University and Tohoku Medical and Pharmaceutical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tohoku Medical and Pharmaceutical University and Tohoku Medical and Pharmaceutical University Hospital
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
Tohoku Medical and Pharmaceutical University and Tohoku Medical and Pharmaceutical University Hospital
Address
1-12-1, Fukumuro, Miyagino-ku, Sendai, Miyagi, Japan
Tel
0222591221
m05009hi@jichi.ac.jp
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
| 2025 | Year | 07 | Month | 31 | 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
10
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
14 or 30 day-mortality rates
Management information
Registered date
| 2025 | Year | 07 | Month | 31 | Day |
Last modified on
| 2025 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067073
