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

Antibiotic Resistant Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03980197
• Other study ID #: 2019-0274
• Status: Recruiting
• Phase: N/A
• Start date: June 3, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: June 2019
• Source: Asan Medical Center
• Contact: Jiwon Jung, MD
• Phone: 82-10-3010-5041
• Email: trueblue27[@]naver.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Antibiotic Resistant Infection

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Sung-Han Kim

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of bloodstream infection due to MDRGNB	Rate of bloodstream infection due to MDRGNB	through study completion, an average 6 months
Secondary	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
Secondary	Days of ICU stay	Days of ICU stay	through study completion, an average 6 months
Secondary	28-day mortality rate	28-day mortality rate	28-days