UMIN-ICDS Clinical Trial

Public title

The Role of Gram's Stain-Driven Antimicrobial Stewardship in the Management of Bacterial Infections: A Systematic Literature Review

Acronym

Gram's Stain-Driven Antimicrobial Stewardship

Scientific Title

The Role of Gram's Stain-Driven Antimicrobial Stewardship in the Management of Bacterial Infections: A Systematic Literature Review

Scientific Title:Acronym

Gram's Stain-Driven Antimicrobial Stewardship

Region

Japan

Condition

bacterial infection

Classification by specialty

Medicine in general

Infectious disease

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To assess the effectiveness of Gram's stain in antimicrobial stewardship in bacterial infection management.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

antibiotic de-escalation or discontinuation

Key secondary outcomes

mortality, hospital length of stay, cost-effectiveness

Study type

Others,meta-analysis etc

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

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Studies which assessed an impact of Gram's stain on antimicrobial selection, and which had 2 or more defined outcomes of interest including antimicrobial consumption, de-escalation or discontinuation, mortality, hospital length of stay, cost-effectiveness.

Key exclusion criteria

Review articles, conference abstracts, and non-English-language articles.

Target sample size

Name of lead principal investigator

1st name	Hiroshi
Middle name
Last name	Ito

Organization

Tokyo Medical University Ibaraki Medical Center

Division name

Division of General Internal Medicine

Zip code

300-0395

Address

3-20-1 Chuo, Ami-machi, Inashiki-gun, Ibaraki, Japan

TEL

+81-29-887-1161

Email

itohirokan@yahoo.co.jp

Name of contact person

1st name	Hiroshi
Middle name
Last name	Ito

Organization

Tokyo Medical University Ibaraki Medical Center

Division name

Division of General Internal Medicine

Zip code

300-0395

Address

3-20-1 Chuo, Ami-machi, Inashiki-gun, Ibaraki, Japan

TEL

+81-29-887-1161

Homepage URL

Email

itohirokan@yahoo.co.jp

Institute

Tokyo Medical University Ibaraki Medical Center

Institute

Department

Personal name

Organization

None.

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Not applicable.

Address

Not applicable.

Tel

Not applicable.

Email

Not applicable.

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

2022

Year

11

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2022

Year

10

Month

10

Day

Date of IRB

2020

Year

10

Month

10

Day

Anticipated trial start date

2022

Year

10

Month

10

Day

Last follow-up date

2023

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Systematic searches of PubMed and Web of Science will be performed to identify studies that utilized Gram's stain as antimicrobial stewardship techniques between the period January 1996 and September 2022, during which there was a concept of "antimicrobial stewardship." We will search terms as follows: Gram or Gram's stain; initial antibiotic or antimicrobial administration, agent, choice, drug, selection, therapy, or treatment; antibiotic or antimicrobial stewardship; pathogen-targeted therapy or treatment; narrow or narrower-spectrum agent, antibiotic, or antimicrobial; broad-spectrum agent, antibiotic, or antimicrobial; empiric or empirical administration, therapy, treatment, selection, or use; guideline; gold standard; blood or urine culture. In addition, we will conduct a manual search of the reference lists of relevant articles.
Studies which assessed an impact of Gram's stain on antimicrobial selection, and which had 2 or more defined outcomes of interest including antimicrobial consumption, de-escalation or discontinuation, mortality, hospital length of stay, cost-effectiveness, and other outcomes such as incidence of infection, clinical failure, and adverse events will be included. Review articles, conference abstracts, and non-English-language articles will be excluded.
Relevant studies will be identified based on a title and abstract screening done independently by 2 researchers, followed by a full-text review of the shortlisted studies. Any disagreements on inclusion will be resolved by discussion with a third researcher.
This systematic literature review will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) methodology.

Registered date

2022

Year

10

Month

10

Day

Last modified on

2023

Year

03

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056013