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

NCT03980197 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2500

Last updated 2019-06-10

No results posted yet for this study

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.

Conditions

  • Antibiotic Resistant Infection

Interventions

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.

OTHER

Control

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

Sponsors & Collaborators

  • Sung-Han Kim

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-03
Primary Completion
2020-06-30
Completion
2020-06-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03980197 on ClinicalTrials.gov