Skip to content

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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03980197
Enrollment
2500
Registered
2019-06-10
Start date
2019-06-03
Completion date
2020-06-30
Last updated
2019-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibiotic Resistant Infection

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.

Interventions

OTHERActive surveillance and preemptive isolation

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

OTHERControl

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

Sponsors

Sung-Han Kim
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The number of patients who acquired MDRGNB in ICU per 1000 patient-daysthrough study completion, an average 6 monthsThe number of patients who acquired MDRGNB in ICU per 1000 patient-days

Secondary

MeasureTime frameDescription
Rate of bloodstream infection due to MDRGNBthrough study completion, an average 6 monthsRate of bloodstream infection due to MDRGNB
Hand hygiene compliance rates (%) of healthcare workersthrough study completion, an average 1 yearnumber of Hand hygiene compliance/number of opportunicities for hand hygiene of healthcare workers \*100
Days of ICU staythrough study completion, an average 6 monthsDays of ICU stay
28-day mortality rate28-days28-day mortality rate

Countries

South Korea

Contacts

Primary ContactJiwon Jung, MD
trueblue27@naver.com82-10-3010-5041
Backup ContactSung-Han Kim, MD
kimsunghanmd@hotmail.com82-10-3010-3305

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026