NCT03980197

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

Status unknown NA Last updated 10 June 2019

What this trial tests

NA trial testing Active surveillance and preemptive isolation in Antibiotic Resistant Infection in 2,500 participants. Status unknown.

Timeline

3 June 2019

Primary endpoint
30 June 2020

30 June 2020

Quick facts

Lead sponsor	Sung-Han Kim
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	prevention
Enrollment	2,500
Start date	3 June 2019
Primary completion	30 June 2020
Estimated completion	30 June 2020
Sites	1 location across South Korea

Drugs / interventions tested

• Active surveillance and preemptive isolation
• Control

Conditions studied

• Antibiotic Resistant Infection — all drugs for Antibiotic Resistant Infection →

Sponsor

Sung-Han Kim

Who can join

Eligibility, female only, with Antibiotic Resistant Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Active surveillance testing to reduce transmission of carbapenem-resistant, gram-negative bacteria in intensive care units: a pragmatic, randomized cross-over trial.
   Jung J, Park JH, Yang H, Lim YJ, et al · · 2023 · cited 7× · PMID 36869371 · DOI 10.1186/s13756-023-01222-2