UMIN-CTR Clinical Trial

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

bacteremia

Classification by specialty

Intensive care medicine

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

National Hospital Organization Kyoto Medical Center

Institute

Department

Personal name

Organization

self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

05

Month

07

Day

URL releasing protocol

Publication of results

Published

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

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 related information

observational study

Registered date

2018

Year

05

Month

07

Day

Last modified on

2018

Year

11

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037062