UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041639 |
|---|---|
| Receipt number | R000046579 |
| Scientific Title | Prospective observational study to evaluate appropriate dose and efficacy of cephamycin and oxacephem for invasive UTI due to ESBL-E. coli |
| Date of disclosure of the study information | 2020/09/01 |
| Last modified on | 2023/03/07 16:22:01 |
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Basic information
Public title
Prospective observational study to evaluate appropriate dosage and efficacy of cephamycin and oxacephem for invasive UTI due to ESBL-E. coli
Acronym
CMZ/FMOX for ESBL-E. coli UTI
Scientific Title
Prospective observational study to evaluate appropriate dose and efficacy of cephamycin and oxacephem for invasive UTI due to ESBL-E. coli
Scientific Title:Acronym
CMZ/FMOX for ESBL-E. coli UTI
Region
| Japan |
Condition
Condition
invasive UTI
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
<clinical assessment>
To compare the clinical outcome of cases of invasive urinary tract infection definitively treated with cefamycin oxacephem with carbapenem.
<PK/PD assessment>
To explore an appropriate dosage regimen for cephamycin and oxacephem by analyzing PK/PD simulations and clinical outcomes in definitively treated cases.
<Microbiological evaluation>
To evaluate drug susceptibility and molecular epidemiological characteristics on ESBL-producing Escherichia coli strains involved in invasive urinary tract infections collected from multiple centers in Japan
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bacteriological and clinical efficacy in the early stage of treatment with intravenous cephamycin/oxacephem or carbapenem (days 4 to 6 after initiation of treatment [start date = day 1])
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Over 20 years old
Patients with a fever of 37.5 or more, or any of the following: back pain, flank pain pain, or renal pain
Confirmation of pyuria prior to initiation of antimicrobials by any of the following criteria
1) Urine sediment: >=5 WBCs/HPF
2) Non-centrifugation urine: >=10 WBCs/microL
3) Urine test paper method using non-centrifuged urine (based on the principle of measuring esterase activity): Positive
ESBL-producing E. coli detected in urine (>= 104 CFU/mL)
In cases where ESBL-producing E. coli is detected in blood only, no other source of infection other than the urinary tract is found.
within 3 days of the submission of urine culture any of the study drugs must be started.
The eligible drug must be cefmetazole (cephamycin), flomoxef (oxacephem), or carbapenem (meropenem).
Empirical antimicrobial treatment with other agents prior to initiation is acceptable, but the patient must have been switched to one of the study drugs within 48 hours.
Patients must have used the study drug for at least 4 consecutive days (including the day of initiation).
Patients who have been switched to an effective oral antimicrobial agent after receiving the target drug will also be considered eligible patients.
Key exclusion criteria
Patients with a history of invasive urinary tract infection within 4 weeks prior to onset
- Patients with concomitant use of antimicrobial agents (beta-lactams, aminoglycosides, fluoroquinolones, ST-fusions, colistin, tigecycline, minomycin, doxycycline, nitrofurantoin, and fosfomycin) that may be effective against ESBL-producing E. coli in addition to the study drug.
- Persons with a history of hypersensitivity to cephem and carbapenem antibiotics
- Dialysis patients (hemodialysis and peritoneal dialysis)
- Other items that the principal investigator deems inappropriate for inclusion in the research
Target sample size
78
Research contact person
Name of lead principal investigator
| 1st name | Kayoko |
| Middle name | |
| Last name | HAYAKAWA |
Organization
NCGM
Division name
DCC
Zip code
1628655
Address
1-21-1 Toyama Sjinjuku Tokyo Japan
TEL
03-3202-7181
khayakawa@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Kayoko |
| Middle name | |
| Last name | Hayakawa |
Organization
NCGM
Division name
DCC
Zip code
1628655
Address
1-21-1 Toyama Sjinjuku Tokyo Japan
TEL
03-3202-7181
Homepage URL
khayakawa@hosp.ncgm.go.jp
Sponsor or person
Institute
NCGM
Institute
Department
Personal name
Funding Source
Organization
NCGM
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NCGM
Address
1-21-1 Toyama Sjinjuku Tokyo Japan
Tel
03-3202-7181
rinri@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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 01 | 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
Completed
Date of protocol fixation
| 2019 | Year | 11 | Month | 18 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 06 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 06 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 01 | Month | 31 | Day |
Other
Other related information
Epidemiological characteristics, outcome, microbiological information
Management information
Registered date
| 2020 | Year | 09 | Month | 01 | Day |
Last modified on
| 2023 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046579
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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