Strategy to Prevent Transmission of Multidrug-resistant Gram-negative Organisms in ICU
NCT ID: NCT03980197
Last Updated: 2019-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
2500 participants
INTERVENTIONAL
2019-06-03
2020-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
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Intervention
Active surveillance test and preemptive isolation is performed. If MDRO is isolated in surveillance test, contact precaution is needed.
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
No active surveillance test and preemptive isolation performed. Only standard precaution is needed, and if clinical isolates reveals MDRO, start contact precaution.
Control
No active surveillance and preemptive isolation. If clinical isolates are positive for MDRGNB, start contact precaution
Interventions
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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
No active surveillance and preemptive isolation. If clinical isolates are positive for MDRGNB, start contact precaution
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
FEMALE
No
Sponsors
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Sung-Han Kim
OTHER
Responsible Party
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Sung-Han Kim
Princiapl investigator
Locations
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Asan Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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Jung J, Park JH, Yang H, Lim YJ, Kim EO, Lim CM, Kim MN, Jo MW, Yun SC, Kim SH. Active surveillance testing to reduce transmission of carbapenem-resistant, gram-negative bacteria in intensive care units: a pragmatic, randomized cross-over trial. Antimicrob Resist Infect Control. 2023 Mar 3;12(1):16. doi: 10.1186/s13756-023-01222-2.
Other Identifiers
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2019-0274
Identifier Type: -
Identifier Source: org_study_id
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