Strategy to Prevent Transmission of Multidrug-resistant Gram-negative Organisms in ICU

NCT ID: NCT03980197

Last Updated: 2019-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

2500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-03

Study Completion Date

2020-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

1. Objective of study The purpose of this study was to investigate whether the active surveillance and preemptive isolation of multidrug-resistant Gram-negative bacteria in the intensive care unit affected the reduction of the rate of acquisition of multidrug- resistant Gram-negative bacteria (MDRGNB).
2. Background Treatment option for MDRGNB (Carbapenem-resistant P. aeruginosa, Carbapenem-resistant A. baumannii, Carbapenem-resistant Enterobacteriaceae) is limited. Development of infection due to MDRGNB is common in ICU. Strategy to prevent transmission of MDRGNB is needed, and there is two approaches; First, antimicrobial stewardship program, and second, infection control strategy.The investigators aimed to figure out the role of active surveillance test and preemptive isolation of MDRGNB in reduction of acquisition rate of MDRGNB.
3. Methods Pragmatic cluster randomized, crossover, controlled trial During first period (6 months), intervention group (randomized 3 ICUs) perform daily chlorhexidine bathing, active surveillance test and preemptive isolation and contact precaution. Control group (randomized 3 ICUs) perform standard precaution with daily chlorhexidine bathing, and start contact precaution when clinical isolates reveals MDRGNB.

After 1 month washout period, intervention group and control group cross over for next 6 months.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Antibiotic Resistant Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention

Active surveillance test and preemptive isolation is performed. If MDRO is isolated in surveillance test, contact precaution is needed.

Group Type EXPERIMENTAL

Active surveillance and preemptive isolation

Intervention Type OTHER

Active surveillance test and preemptive isolation is performed. If MDRO is isolated in surveillance test, contact precaution is needed.

Control

No active surveillance test and preemptive isolation performed. Only standard precaution is needed, and if clinical isolates reveals MDRO, start contact precaution.

Group Type ACTIVE_COMPARATOR

Control

Intervention Type OTHER

No active surveillance and preemptive isolation. If clinical isolates are positive for MDRGNB, start contact precaution

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Active surveillance and preemptive isolation

Active surveillance test and preemptive isolation is performed. If MDRO is isolated in surveillance test, contact precaution is needed.

Intervention Type OTHER

Control

No active surveillance and preemptive isolation. If clinical isolates are positive for MDRGNB, start contact precaution

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Enroll all patients who admit to the ICUs during the study period

Exclusion Criteria

* Patients who discharge within 2 days after admission to ICUs
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sung-Han Kim

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sung-Han Kim

Princiapl investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Asan Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jiwon Jung, MD

Role: CONTACT

82-10-3010-5041

Sung-Han Kim, MD

Role: CONTACT

82-10-3010-3305

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jiwon Jung, MD

Role: primary

82-10-3010-5041

References

Explore related publications, articles, or registry entries linked to this study.

Jung J, Park JH, Yang H, Lim YJ, Kim EO, Lim CM, Kim MN, Jo MW, Yun SC, Kim SH. Active surveillance testing to reduce transmission of carbapenem-resistant, gram-negative bacteria in intensive care units: a pragmatic, randomized cross-over trial. Antimicrob Resist Infect Control. 2023 Mar 3;12(1):16. doi: 10.1186/s13756-023-01222-2.

Reference Type DERIVED
PMID: 36869371 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2019-0274

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.