UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of an application of empirical antimicrobial protocol in critical care settings: A single-center, retrospective observational cohort study
Title of the study (Brief title)	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	Kei Nishiyama
Organization	National Hospital Organization Kyoto Medical Center
Division name	Department of Emergency and Critical Care Medicine
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	Nobuaki Shime
Organization	Hiroshima University
Division name	Department of Emergency and Critical Care Medicine,Institute of Biomedical & Health Sciences
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2018 Year 05 Month 07 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://linkinghub.elsevier.com/retrieve/pii/S1341321X18302721
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.
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/icdr_e/ctr_view.cgi?recptno=R000037062