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

Strategy to Prevent Transmission of Multidrug-resistant Gram-negative Organisms in ICU - Evaluation of Effect of Active Surveillance Test

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.

Study Overview

• Status: Unknown
• Conditions: Antibiotic Resistant Infection
• Intervention / Treatment: Other: Active surveillance and preemptive isolation; Other: Control

• Study Type: Interventional
• Enrollment (Anticipated): 2500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiwon Jung, MD; Phone Number: 82-10-3010-5041; Email: trueblue27@naver.com
• Study Contact Backup: Name: Sung-Han Kim, MD; Phone Number: 82-10-3010-3305; Email: kimsunghanmd@hotmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 05505
    • Recruiting
    • Asan Medical Center
    • Contact: Jiwon Jung, MD; Phone Number: 82-10-3010-5041; Email: trueblue27@naver.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention; 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; Active surveillance test and preemptive isolation is performed. If MDRO is isolated in surveillance test, contact precaution is needed.
ACTIVE_COMPARATOR: Control; No active surveillance test and preemptive isolation performed. Only standard precaution is needed, and if clinical isolates reveals MDRO, start contact precaution.	Other: Control; No active surveillance and preemptive isolation. If clinical isolates are positive for MDRGNB, start contact precaution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of bloodstream infection due to MDRGNB	Rate of bloodstream infection due to MDRGNB	through study completion, an average 6 months
Hand hygiene compliance rates (%) of healthcare workers	number of Hand hygiene compliance/number of opportunicities for hand hygiene of healthcare workers *100	through study completion, an average 1 year
Days of ICU stay	Days of ICU stay	through study completion, an average 6 months
28-day mortality rate	28-day mortality rate	28-days

Collaborators and Investigators

• Sponsor: Sung-Han Kim

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 3, 2019
• Primary Completion (ANTICIPATED): June 30, 2020
• Study Completion (ANTICIPATED): June 30, 2020

Study Registration Dates

• First Submitted: June 4, 2019
• First Submitted That Met QC Criteria: June 6, 2019
• First Posted (ACTUAL): June 10, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 10, 2019
• Last Update Submitted That Met QC Criteria: June 6, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 2019-0274

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No