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

Study Overview
=================
Brief Summary
-----------------
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). 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. 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.

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

Conditions
-----------------
Antibiotic Resistant Infection

Intervention / Treatment
-----------------
* Other: Active surveillance and preemptive isolation
* Other: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
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
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* Active surveillance test and preemptive isolation is performed. If MDRO is isolated in surveillance test, contact precaution is needed.<br>|
| Active Comparator: Control<br>No active surveillance test and preemptive isolation performed. Only standard precaution is needed, and if clinical isolates reveals MDRO, start contact precaution. | Other: Control<br>* No active surveillance and preemptive isolation. If clinical isolates are positive for MDRGNB, start contact precaution<br>|

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 |