UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000032494
Receipt No. R000037062
Scientific Title Effects of an application of empirical antimicrobial protocol in critical care settings: A single-center, retrospective observational cohort study
Date of disclosure of the study information 2018/05/07
Last modified on 2018/11/06

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effects of an application of empirical antimicrobial protocol in critical care settings: A single-center, retrospective observational cohort study
Acronym Effects of an application of empirical antimicrobial protocol in critical care settings: A single-center, retrospective observational cohort study
Scientific Title Effects of an application of empirical antimicrobial protocol in critical care settings: A single-center, retrospective observational cohort study
Scientific Title:Acronym Effects of an application of empirical antimicrobial protocol in critical care settings: A single-center, retrospective observational cohort study
Region
Japan

Condition
Condition bacteremia
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of protocol on prescribing patterns of early antimicrobials, as well as on outcomes in patients with bacteremia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes the 28-day survival rate
Key secondary outcomes the appropriateness of early empirical antimicrobials; broad-spectrum/narrow-spectrum ratio; antimicrobial-related costs; and rate of use of meropenem

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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients admitted to the critical care center that had positive blood cultures, and together with the clinical symptoms, were diagnosed with bacteremia.
Key exclusion criteria Not applicable
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kei Nishiyama
Organization National Hospital Organization Kyoto Medical Center
Division name Department of Emergency and Critical Care Medicine
Zip code
Address 1-1 Fukakusa, Mukaihata-cho, Fushimi-ku, Kyoto, Japan
TEL 075-641-9161
Email keinishi@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobuaki Shime
Organization Hiroshima University
Division name Department of Emergency and Critical Care Medicine,Institute of Biomedical & Health Sciences
Zip code
Address 1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan
TEL 082-257-5456
Homepage URL
Email shime@koto.kpu-m.ac.jp

Sponsor
Institute National Hospital Organization Kyoto Medical Center
Institute
Department

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
Email

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
2018 Year 05 Month 07 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://linkinghub.elsevier.com/retrieve/pii/S1341321X18302721
Number of participants that the trial has enrolled
Results
In the treatment of severe infections in critical care settings, the selection of initial empirical antimicrobials affects patient outcomes and antimicrobial overuse. The application of a comprehensive treatment guidance might facilitate appropriate antimicrobial selection. Therefore, we developed such an antimicrobial guidance for use in emergency and critical care center and verified its efficacy. We retrospectively analyzed the data of 195 patients (96 patients before guidance introduction [control group] and 99 after guidance introduction [intervention group]) who were ultimately diagnosed with bacteremia to assess the effects of the guidance (the intervention). The appropriateness of the empirical therapy was greater in the intervention than in the control group (96% vs. 90%, respectively; P = 0.10). Moreover, the rate of carbapenem use was significantly lower in the intervention than in the control group (6% vs. 20%, respectively; P < 0.01). The control and intervention groups had similar 28-day survival rates of 81% and 85%, respectively; P = 0.50). These findings imply that introducing an empirical antimicrobial guidance in emergency outpatient and emergency intensive care settings could improve antimicrobial stewardship without affecting patient mortality. The data of this study can be used as a reference for establishing the study design of a large-scale prospective trial, aimed at verifying guidance efficacy.
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 Main results already published
Date of protocol fixation
2018 Year 05 Month 07 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information observational study

Management information
Registered date
2018 Year 05 Month 07 Day
Last modified on
2018 Year 11 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037062

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.