UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037140 |
|---|---|
| Receipt number | R000042326 |
| Scientific Title | Impact of beta-lactamase detection reagent on rapid diagnosis of ESBL-producing pathogens |
| Date of disclosure of the study information | 2019/06/23 |
| Last modified on | 2022/12/27 09:19:02 |
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Basic information
Public title
Impact of beta-lactamase detection reagent on rapid diagnosis of ESBL-producing pathogens
Acronym
Impact of beta-lactamase detection reagent on rapid diagnosis of ESBL-producing pathogens
Scientific Title
Impact of beta-lactamase detection reagent on rapid diagnosis of ESBL-producing pathogens
Scientific Title:Acronym
Impact of beta-lactamase detection reagent on rapid diagnosis of ESBL-producing pathogens
Region
| Japan |
Condition
Condition
Urinary tract infection
Classification by specialty
| Infectious disease | Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether beta-lactamase detection reagent appropriately detect ESBL-producing pathogens in urine.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitivity and specificity of beta-lactamase detection reagent in detecting ESBL producing pathogens.
Key secondary outcomes
1. Comparison of sensitivity and specificity among pathogens.
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 are performed urine culture tests and whose Gram stain of urine detected Gram negetive pathogens at least 1+.
Key exclusion criteria
non
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Jumpei |
| Middle name | |
| Last name | Yoshimura |
Organization
Osaka General Medical Center
Division name
Division of Trauma and Surgical Critical Care
Zip code
558-8558
Address
3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka 558-8558, Japan
TEL
06-6692-1201
jumpei.y0210@gmail.com
Public contact
Name of contact person
| 1st name | Jumpei |
| Middle name | |
| Last name | Yoshimura |
Organization
Osaka General Medical Center
Division name
Division of Trauma and Surgical Critical Care
Zip code
558-8558
Address
3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka 558-8558, Japan
TEL
06-6692-1201
Homepage URL
jumpei.y0210@gmail.com
Sponsor or person
Institute
Osaka General Medical Center
Institute
Department
Personal name
Funding Source
Organization
non
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
Osaka General Medical Center
Address
3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka 558-8558, Japan
Tel
06-6692-1201
kenkyusien@gh.opho.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
| 2019 | Year | 06 | Month | 23 | Day |
Related information
URL releasing protocol
UMIN000037140
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S1201971221007669?via%3Dihub
Number of participants that the trial has enrolled
350
Results
In total, 350 urine samples were analysed. Urinary tract infection (UTI) was diagnosed in 214 patients. ESBL-producing Enterobacterales were isolated from 79 samples. The Cica-beta test showed sensitivity of 79.8% and specificity of 99.3% in patients with Gram-negative bacteriuria. Sensitivity and specificity improved to 90.2% and 100%, respectively, in patients with UTI.
Results date posted
| 2022 | Year | 12 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
From July 2019 to November 2019, 1117 consecutive patients on whom urine culture tests were performed were initially Eli- gible. Of these, 767 patients were excluded as 759 did not have Gram-negative bacteriuria and eight had haematuria. Therefore, 350 patients with Gram-negative bacteriuria were included in this study, and the Cica-beta test was performed directly on their urine samples. Among these 350 patients, 214 were diagnosed with UTI.
Participant flow
Patients were eligible if they underwent urine culture tests, and Gram-negative pathogens of at least one per field of view under a 1000x microscope were detected from their urine samples. Patients with haematuria were excluded because it was not possible to evaluate the colour change of the Cica-beta reagent
Adverse events
none
Outcome measures
The primary endpoint was defined as the diagnostic accuracy of the Cica-beta test for ESBL-producing Enterobacterales in patients with bacteriuria or UTI. In this study, patients with UTI were re- garded as those who started antibiotic therapy with a diagnosis of UTI by the attending physicians when urine culture tests were per- formed. Secondary endpoints were set as the turnaround times of the Cica-beta test and standard antibiotic susceptibility tests.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 04 | Month | 23 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 23 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We use beta-lactamase detection reagent to urine samples. We determine whether ESBL producing pathogens are existed in urine samples by color change of a test strip.
Management information
Registered date
| 2019 | Year | 06 | Month | 23 | Day |
Last modified on
| 2022 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042326
