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

Sung-Han Kim

Status: Unknown

Conditions: Antibiotic Resistant Infection

Treatments: Other: Active surveillance and preemptive isolation; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT03980197

2019-0274

Details and patient eligibility

About

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.

Enrollment: 2,500 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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2,500 participants in 2 patient groups

Intervention

Experimental group

Description:

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

Treatment:

Other: Active surveillance and preemptive isolation

Control

Active Comparator group

Description:

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

Treatment:

Other: Control