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

Not Applicable

• Conditions: Antibiotic Resistant Infection
• Interventions: Other: Active surveillance and preemptive isolation; Other: Control

• Registration Number: NCT03980197
• Lead Sponsor: Sung-Han Kim

Brief Summary

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

Not available

Study Timeline

• Status Verified: 2019-06
• Study Start: 2019-06-03
• Study First Submitted: 2019-06-04
• Study First Submitted QC: 2019-06-06
• Last Update Submitted: 2019-06-06
• Study First Posted: 2019-06-10
• Last Update Posted: 2019-06-10
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 2500

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intervention	Active surveillance and preemptive isolation	Active surveillance test and preemptive isolation is performed. If MDRO is isolated in surveillance test, contact precaution is needed.
Control	Control	No active surveillance test and preemptive isolation performed. Only standard precaution is needed, and if clinical isolates reveals MDRO, start contact precaution.

Primary Outcome Measures

Name	Time	Method
The number of patients who acquired MDRGNB in ICU per 1000 patient-days	through study completion, an average 6 months	The number of patients who acquired MDRGNB in ICU per 1000 patient-days

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of