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

NCT03980197 | Unknown

• 1 other identifier: 2019-0274
• Study Type: interventional
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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. 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.

Conditions

Antibiotic Resistant Infection

Outcome Measures

Primary Outcomes (1)

• The number of patients who acquired MDRGNB in ICU per 1000 patient-days

  The number of patients who acquired MDRGNB in ICU per 1000 patient-days

  through study completion, an average 6 months

Secondary Outcomes (4)

• Rate of bloodstream infection due to MDRGNB

  through study completion, an average 6 months

• Hand hygiene compliance rates (%) of healthcare workers

  through study completion, an average 1 year

• Days of ICU stay

  through study completion, an average 6 months

• 28-day mortality rate

  28-days

Study Arms (2)

Intervention

EXPERIMENTAL

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

Other: Active surveillance and preemptive isolation

Control

ACTIVE COMPARATOR

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

Other: Control

Interventions

Active surveillance and preemptive isolation OTHER

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

Intervention

Control OTHER

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

Control

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients who discharge within 2 days after admission to ICUs

Sponsors & Collaborators

• Sung-Han Kim: lead

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

Related Publications (1)

• 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.

  PMID: 36869371 DERIVED

MeSH Terms

Interventions

Watchful Waiting

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Central Study Contacts

Jiwon Jung, MD

CONTACT

82-10-3010-5041; trueblue27@naver.com

Sung-Han Kim, MD

CONTACT

82-10-3010-3305; kimsunghanmd@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Princiapl investigator

Study Record Dates

• First Submitted: June 4, 2019
• First Posted: June 10, 2019
• Study Start: June 3, 2019
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: June 10, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)