An interventional study of Daily Chlorhexidine Bathing and Antimicrobial and PPI Stewardship Program in Carbapenemase-Producing Enterobacteriaceae (CPE) and Healthcare-Associated Infections (HAIs), sponsored by Chuncheon Sacred Heart Hospital. Enrolling by invitation at 3 sites in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2025-07-23.
Sponsored by Chuncheon Sacred Heart Hospital · Not applicable, Interventional, and Prevention
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.
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.
285 studies on the registry are indexed under Cross Infection; 48 are open to participants now.
This study's planned enrollment of 5,760 is above the median of 185 across 169 interventional studies indexed under Cross Infection.
Browse Cross Infection studies →Chuncheon Sacred Heart Hospital is the lead sponsor of 56 studies on the registry; 8 are open to participants now.
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Admitted to one of the participating intensive care units (ICUs):
Exclusion Criteria:
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Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients admitted to intensive care units (ICUs) assigned to the intervention group will receive daily bathing using no-rinse, 4% chlorhexidine gluconate (CHG)-impregnated washcloths. In addition, targeted antimicrobial stewardship focused on reducing unnecessary carbapenem use and PPI stewardship aimed at limiting inappropriate PPI prescriptions will be implemented.
Behavioral: Daily Chlorhexidine Bathing · Behavioral: Antimicrobial and PPI Stewardship Program
Patients admitted to ICUs assigned to the control group will receive standard daily bathing without chlorhexidine. The same antimicrobial and PPI stewardship interventions applied in the intervention group will also be implemented in the control group.
Behavioral: Antimicrobial and PPI Stewardship Program · Behavioral: Standard Bathing
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.
Incidence of CPE Colonization and Infection
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: From ICU admission up to ICU discharge (an average of 10-14 days)
Residual CHG Skin Concentration vs. CPE MIC Comparison
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: Measured at 3-month intervals during intervention periods
Proportion of CHG Bathing Days Adherent to Protocol Based on CHG Skin Concentration, Checklist Compliance, and EMR Audit
This outcome assesses adherence to the daily chlorhexidine gluconate (CHG) bathing protocol among ICU patients. Adherence will be evaluated using a combination of: 1. Colorimetric CHG skin concentration testing, with adherence defined as CHG concentration ≥125 µg/mL on at least 2 of 3 body sites; 2. Chlorhexidine Bathing Checklist completed by bedside staff; and 3. Electronic Medical Record (EMR) audit for daily documentation of CHG bathing. Feedback on adherence results will be provided to ICU staff, and its impact on improving adherence rates will be evaluated.
Time frame: Approximately Day 15 of Months 0, 3, and 6 during the intervention period
Incidence of Adverse Skin Reactions Related to CHG Bathing
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: Daily during the intervention period, from ICU admission up to ICU discharge (an average of 10-14 days)
Monthly Trends in Antimicrobial and PPI Use
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.
Time frame: Monthly, from intervention start (Month 1) to study end (Month 12)
Plan to share: No — Individual participant data will not be shared due to privacy concerns and the nature of the cluster-level intervention design.
Started Jul 2025 (actual). Primary completion is estimated for Jul 2026, 12 months after the start.
Of 57 non-industry interventional studies with no phase under Cross Infection, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 29. This study's planned 12 months is below that.
Counting every sponsor, half of 59 studies reached it within 16 months; a quarter within 6 and three quarters within 29.
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Chuncheon Sacred Heart Hospital