UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049016 |
|---|---|
| Receipt number | R000055809 |
| Scientific Title | Randomised Controlled Trial of Meropenem versus Cefmetazole for definitive treatment of bloodstream infections due to ESBL- producing Escherichia coli |
| Date of disclosure of the study information | 2022/09/26 |
| Last modified on | 2023/11/08 12:52:29 |
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Basic information
Public title
Randomised Controlled Trial of Meropenem versus Cefmetazole for definitive treatment of bloodstream infections due to ESBL- producing Escherichia coli
Acronym
CEFMEC Trial
Scientific Title
Randomised Controlled Trial of Meropenem versus Cefmetazole for definitive treatment of bloodstream infections due to ESBL- producing Escherichia coli
Scientific Title:Acronym
CEFMEC Trial
Region
| Japan |
Condition
Condition
bloodstream infections due to ESBL- producing Escherichia coli
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this trial is to show that cefmetazole (a carbapenem-sparing therapy) is non-inferior to meropenem (a widely used carbapenem) in definitive treatment of bloodstream infections due to ESBL- producing Escherichia coli
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
30-day all-cause mortality of cefmetazole and meropenem after bloodstream infection (randomized day = day 1)
Key secondary outcomes
1) 14-day all-cause mortality of cefmetazole and meropenemafter bloodstream infection (randomized day = day 1)
2) Microbiological success rate: defined as negative blood cultures taken on or before day 5 (randomized day = day 1).
3) Clinical success rate: resolution of fever (body temperature [axillary temperature] 37.5 Celsius or higher) and leukocytosis (WBC>12000/micro-liter) on or before day 5 (randomized days = day 1)
4) clinical and microbiological success rate: 2) and 3)
5) Time to resolution of fever: Number of days from randomization to resolution of fever (eg, if fever resolved on the next day of randomization, count as 1 day). Resolution of fever is defined as temperature less than or equal to 37.5 Celsius for at least 24 hours.The first day when the temperature becomes below 37.5 Celsius is recorded.
6) Recurrence of bloodstream infection: Bloodstream infection due to ESBL-producing E. coli by day 30 after the end of the study drug administration period (randomized day = day 1)
7) Detection rate of carbapenem-resistant bacteria or cefmetazol-resistant bacteria, or incidence of Clostridioides difficile infection: Isolation of carbapenem-resistant organisms (CROs) or cefmetazole resistant organisms (CMZROs) from clinical specimens (excluding specimens for surveillance purposes) or positive stool tests for C. difficile toxin from day 5 of study drug administration to day 30 of randomization.
8) Ordinal scale evaluation by Desirability of Outcome Ranking (DOOR)
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
Study drug: cefmetazole sodium
Cefmetazole 1g intravenously (over 30 minutes) every 8 hours. For 5 day to 14 days.
Interventions/Control_2
Control drug: Meropenem hydrate
Meropenem 1g intravenously (over 30 minutes) every 8 hours. For 5 day to 14 days.
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
1) Patient or whose legal representatives provided written informed consent for the study participation
2) Persons who are 18 years of age or older at the time of obtaining consent
3) Within 72 hours from the time of the first blood culture collection
4) E. coli isolated from blood meetsany of the following
1. ceftriaxone or cefotaxime-resistant (MIC 2mg/L or higher), meropenem-sensitive (MIC 1mg/L or lower), and cefmetazole MIC 16mg/L or lower
2. E. coli and CTX-M gene are positive in the genetic testing system and any carbapenemase gene is negative
3. ESBL productivity of E. coli is confirmed or strongly suspected (e.g. ESBL pattern in beta-lactamase detection kit or ESBL screening medium test positive)
If a patient is enrolled by meeting criteria 4) 2 or 4) 3, however, later, 4) 1 is found out not to be satisfied, then, the participation in the study will be discontinued.
Key exclusion criteria
1) Participation in other intervention studies
2) History of allergy to cefmetazole or carbapenem
3) Bacteremia due to multiple bacteria (excluding skin contaminants)
4) Patients expected to die within 4 days after randomization (randomized day = day 1)
5) Patients who are expected to be difficult to follow during the first 30 days after randomization (day of randomization = day 1)
6) Pregnant women and breastfeeding women
7) Patients on dialysis or patients whose creatinine clearance (based on Cockcroft-Gault formula) is less than 10ml/min
8) Patients expected to receive additional antibiotics active against Gram-negative bacilli by day 5 after randomization (excluding sulfamethoxazole and trimethoprim for prevention of Pneumocystis pneumonia) (day of randomization = Day 1)
9) Confirmed or strongly suspected carbapenemase-producing or AmpC-producing E. coli from blood culture (e.g. carbapenemase-positive with carbapenemase detection kit or AmpC pattern-positive with beta-lactamase detection kit, carbapenemase screening medium positive)
10) Patients currently using sodium valproate or expected to use it by day 5 after randomization (randomized day = day 1)
11) Persons who are judged inappropriate for inclusion in the research by the principal investigator at each test site
Target sample size
169
Research contact person
Name of lead principal investigator
| 1st name | Kayoko |
| Middle name | |
| Last name | Hayakawa |
Organization
National Center for Global Health and Medicine
Division name
Disease Control and Prevention Center
Zip code
162-8655
Address
1-21-1 Toyama Shinjuku-ku, Tokyo, Japan
TEL
0332027181
khayakawa@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Kayoko |
| Middle name | |
| Last name | Hayakawa |
Organization
National Center for Global Health and Medicine
Division name
Disease Control and Prevention Center
Zip code
162-8655
Address
1-21-1 Toyama Shinjuku-ku, Tokyo, Japan
TEL
0332027181
Homepage URL
cefmec-dcc@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine, Disease Control and Prevention Center
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Fujita Health University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Certified Review Board of National Center for Global Health and Medicine
Address
1-21-1 Toyama Shinjuku-ku, Tokyo 162-8655, Japan
Tel
03-3202-7181
kenkyu-shinsa@hosp.ncgm.go.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
国立研究開発法人国立国際医療研究センター（東京都）、藤田医科大学（愛知県）、京都大学医学部附属病院（京都府）、市立伊勢総合病院（三重県）、横浜市立大学附属病院（神奈川県）、大分大学医学部附属病院（大分県）、りんくう総合医療センター（大阪府）、京都市立病院（京都府）、自治医科大学附属さいたま医療センター（埼玉県）、新潟大学医歯学総合病院（新潟県） 、静岡県立静岡がんセンター（静岡県）、静岡県立総合病院（静岡県）、奈良県立医科大学（奈良県）、兵庫県立はりま姫路総合医療センター（兵庫県）、名古屋医療センター（愛知県）、飯塚病院（福岡県）、愛媛県立中央病院（愛知県）、横浜市立みなと赤十字病院（神奈川県）、社会医療法人財団 慈泉会 相澤病院（長野県）、筑波メディカルセンター病院（茨城県）、敬愛会中頭病院（沖縄県）、島根大学医学部附属病院（島根県）、医療法人渓仁会 手稲渓仁会病院（北海道）、大阪市立総合医療センター（大阪府）、洛和会音羽病院（京都府）、安城更生病院（愛知県）、厚生連高岡病院（富山県）、日本赤十字社愛知医療センター名古屋第一病院（愛知県）、富山県立中央病院（富山県）、愛知県がんセンター（愛知県）、伊勢赤十字病院（三重県）、東京都立多摩総合医療センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 26 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Establishment of the DSMB
At the end of the first 50 patients
At the end of the first 98 patients Total DSMB As above, by treatment group
Management information
Registered date
| 2022 | Year | 09 | Month | 26 | Day |
Last modified on
| 2023 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055809
| Research Plan | |
|---|---|
| Registered date | File name |
| 2023/08/29 | CEFMEC protocol 20230606_ver 1.2.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
