NCT Number: NCT07039955
This multicenter, cluster-randomized crossover trial aims to evaluate the effectiveness and safety of a bundled intervention-including daily chlorhexidine bathing and targeted antimicrobial and proton pump inhibitor (PPI) stewardship-for preventing colonization and infection caused by carbapenemase-producing Enterobacteriaceae (CPE) in intensive care units (ICUs) across three university-affiliated hospitals in South Korea.
Each hospital will include two ICUs, randomized to either the intervention or control group for six months, followed by a crossover. The intervention group will receive daily bathing using no-rinse, 4% chlorhexidine gluconate (CHG)-impregnated washcloths along with antimicrobial and PPI stewardship focused on reducing unnecessary carbapenem and PPI use. The control group will receive standard bathing without chlorhexidine, while receiving the same stewardship interventions as the intervention group.
Primary outcomes include the incidence and prevalence of CPE colonization and CPE-attributable healthcare-associated infections such as bloodstream infections, hospital-acquired pneumonia, and urinary tract infections. Secondary outcomes include evaluation of residual CHG skin concentrations, comparison with CHG minimum inhibitory concentrations (MICs) of CPE isolates, impact of feedback on adherence to bathing protocols, and assessment of adverse skin reactions to CHG bathing.
Findings from this study are expected to provide evidence-based guidance on the effectiveness and feasibility of combining daily chlorhexidine bathing with no-rinse, 4% CHG-impregnated washcloths and stewardship interventions to control the spread of CPE in high-risk healthcare settings.
Interested in participating?
Request Info19 year and older
All sexes
Interventional
Not applicable
Chuncheon Sacred Heart Hospital, Hallym University College of Medicine, Chuncheon, Gangwon-do, South Korea
Carbapenemase-producing Enterobacteriaceae (CPE) are a critical public health threat, particularly in healthcare settings where vulnerable patients are at increased risk of colonization and infection. In South Korea, the number of reported CPE cases has increased sharply in recent years, necessitating the implementation of high-impact, evidence-based strategies for prevention and control.
This multicenter, cluster-randomized crossover trial is being conducted in six intensive care units (ICUs) across three university-affiliated hospitals in South Korea. The primary aim of the study is to evaluate the effectiveness and safety of a bundled intervention consisting of daily chlorhexidine bathing and targeted antimicrobial and proton pump inhibitor (PPI) stewardship in reducing CPE colonization and infection.
Each participating hospital will contribute two ICUs. One ICU will initially serve as the intervention unit and the other as the control unit for six months, after which the roles will be crossed over for an additional six months. The intervention group will receive daily bathing using no-rinse, 4% chlorhexidine gluconate (CHG)-impregnated washcloths, along with antimicrobial and PPI stewardship interventions focused on reducing unnecessary use of carbapenems and PPIs. The control group will receive standard bathing without chlorhexidine, while receiving the same stewardship measures as the intervention group.
Primary outcomes include the incidence and prevalence of CPE colonization and CPE-attributable healthcare-associated infections (HAIs), such as bloodstream infections, hospital-acquired pneumonia, and urinary tract infections. Surveillance cultures will be obtained per institutional protocols and national guidelines, including rectal swabs at ICU admission and weekly thereafter.
Secondary outcomes include:
Skin swab samples will be obtained from the neck, axilla, and groin using a standardized technique. CHG concentrations will be analyzed via a semiquantitative colorimetric assay. CPE isolates will undergo broth microdilution testing to determine the MICs of CHG, following modified Clinical and Laboratory Standards Institute (CLSI) guidelines. CPE isolates will undergo broth microdilution MIC testing based on modified CLSI guidelines.
In parallel, antimicrobial and PPI utilization will be monitored using antibiotic use density (AUD) metrics. Stewardship interventions will focus on minimizing unnecessary use of carbapenems and PPIs, particularly for ventilator-associated pneumonia prophylaxis, and promoting use of alternatives where appropriate. Monthly trends in AUDs will be tracked for carbapenems, ampicillin/sulbactam, ceftazidime/avibactam, cefiderocol, colistin, and other key antibiotics, as well as PPIs and H2 blockers.
This study is designed to provide high-quality evidence on the effectiveness and feasibility of bundled interventions for the prevention of CPE transmission and infection in high-risk ICU settings. Findings from this trial may inform national infection control guidelines and support the broader implementation of CHG-based decolonization and stewardship strategies in similar healthcare environments.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Daily bathing using no-rinse, 4% chlorhexidine gluconate (CHG)-impregnated washcloths will be implemented in ICUs assigned to the intervention group. The purpose is to reduce CPE colonization and infection by maintaining effective residual CHG skin concentrations. Bathing will be performed by trained nursing staff following standardized protocols.
A targeted stewardship program will be implemented to reduce unnecessary carbapenem use and inappropriate proton pump inhibitor (PPI) prescriptions. The program includes audit and feedback, education of ICU physicians, and monthly monitoring of antimicrobial and PPI usage. Stewardship activities will be uniformly applied across both intervention and control ICUs.
Patients in ICUs assigned to the control group will receive standard daily bathing without the use of chlorhexidine. No CHG-containing products will be applied. This represents usual care in the participating hospitals.
Time frame: From ICU admission up to ICU discharge (an average of 10-14 days)
Incidence of new colonization or infection with carbapenemase-producing Enterobacteriaceae (CPE) during ICU admission, confirmed through active surveillance cultures (e.g., rectal swab) and clinical diagnostic specimens (e.g., blood, respiratory, or urine cultures).
Infections will be defined according to CDC/NHSN criteria for healthcare-associated infections.
Time frame: Measured at 3-month intervals during intervention periods
Assessment of residual skin concentrations of chlorhexidine gluconate (CHG) using standardized skin swabs, and comparison with the minimum inhibitory concentrations (MICs) of CPE isolates obtained from clinical or surveillance cultures to determine adequacy of CHG exposure.
Time frame: Approximately Day 15 of Months 0, 3, and 6 during the intervention period
This outcome assesses adherence to the daily chlorhexidine gluconate (CHG) bathing protocol among ICU patients. Adherence will be evaluated using a combination of:
Feedback on adherence results will be provided to ICU staff, and its impact on improving adherence rates will be evaluated.
Time frame: Daily during the intervention period, from ICU admission up to ICU discharge (an average of 10-14 days)
Monitoring and reporting of adverse skin reactions (e.g., erythema, rash, itching, blistering) associated with daily chlorhexidine bathing using 4% CHG-impregnated washcloths. Skin assessments will be conducted by trained staff through direct observation and chart review.
Time frame: Monthly, from intervention start (Month 1) to study end (Month 12)
Monthly analysis of antimicrobial and PPI utilization, measured as days of therapy (DOT) per 1,000 patient-days, including carbapenems, ampicillin/sulbactam, ceftazidime/avibactam, cefiderocol, and PPI vs. H2 blocker use.
Chuncheon Sacred Heart Hospital
Other
Effectiveness of Daily Chlorhexidine Bathing and Antibiotic and Proton Pump Inhibitor (PPI) Stewardship in Preventing Transmission and Infection Caused by Carbapenemase-Producing Enterobacteriaceae (CPE)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07685132
Antimicrobial Resistance (AMR), Carbapenem-Resistant Enterobacteriaceae Colonization
Buenos Aires, Buenos Aires F.D., Argentina
View Trial DetailsNCT07593417
Cross Infection, Disease Attributes
Bogotá, Bogota D.C., Colombia
View Trial DetailsNCT07280026
Adherence Interventions, Behavior
Wuhan, Hubei, China
View Trial DetailsNCT01933620
Cross Infection, Disease Attributes
Bethesda, Maryland, United States
View Trial Details