Carbapenemase-Producing Enterobacteriaceae (CPE)NCT07039955
Effect of Daily Chlorhexidine Bathing and Antibiotic/PPI Stewardship on Prevention of CPE Transmission and Infection
A study testing Daily Chlorhexidine Bathing, Antimicrobial and PPI Stewardship Program and Standard Bathing in people with Carbapenemase-Producing Enterobacteriaceae (CPE) and Healthcare-Associated Infections (HAIs), run by Chuncheon Sacred Heart Hospital at 3 sites in South Korea.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Carbapenemase-Producing Enterobacteriaceae (CPE), Healthcare-Associated Infections (HAIs)
- What is being tested?
- Daily Chlorhexidine Bathing, Antimicrobial and PPI Stewardship Program and Standard Bathing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,760 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 14 Jul 2025to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 19 years or older
- Admitted to one of the participating intensive care units (ICUs):
- Chuncheon Sacred Heart Hospital: CICU or NCU
- Wonju Severance Christian Hospital: MICU or NSICU
- Gangneung Asan Hospital: MICU or SICU
Who cannot join
- Age 18 years or younger
- Patients with extensive burns
- Patients with a known hypersensitivity to chlorhexidine
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea3 sites
Chuncheon Sacred Heart Hospital, Hallym University College of Medicine
Chuncheon, Gangwon-do, 24253
Gangneung Asan Hospital, University of Ulsan College of Medicine
Gangneung, Gangwon-do, 25440
Wonju Severance Christian Hospital, Yonsei University Health System
Wŏnju, Gangwon-do, 26426
About this study
Official title: Effectiveness of Daily Chlorhexidine Bathing and Antibiotic and Proton Pump Inhibitor (PPI) Stewardship in Preventing Transmission and Infection Caused by Carbapenemase-Producing Enterobacteriaceae (CPE)
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.
Read more
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.
Read the detailed description
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:
- Assessment of residual CHG skin concentrations at 3-month intervals using standardized skin swabs and comparison of these concentrations with the minimum inhibitory concentrations (MICs) of CPE isolates obtained from clinical and surveillance cultures to evaluate the adequacy of chlorhexidine exposure.
- Evaluation of adherence to CHG bathing protocols through quarterly feedback of CHG skin concentration results to ICU staff.
- Assessment of adverse skin reactions associated with CHG bathing to evaluate its safety in critically ill patients.
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.
- Being tested
- Daily Chlorhexidine Bathing, Antimicrobial and PPI Stewardship Program, Standard Bathing
- Keywords
- Carbapenemase-Producing Enterobacteriaceae, Healthcare-Associated Infections, Intensive Care Unit, infection control, Daily Chlorhexidine Bathing, Antimicrobial Stewardship, Proton Pump Inhibitor Stewardship, Chlorhexidine (CHG) Skin Concentration, Chlorhexidine (CHG) Minimum Inhibitory Concentration (MIC)
- Medical subject headings
- Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily Chlorhexidine BathingBehavioural
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.
Antimicrobial and PPI Stewardship ProgramBehavioural
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.
Standard BathingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CHG Bathing + Antimicrobial/PPI Stewardship | Experimental | 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. Receives: Behavioral: Daily Chlorhexidine Bathing; Behavioral: Antimicrobial and PPI Stewardship Program |
| Standard Bathing + Antimicrobial/PPI Stewardship | Active comparator | 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. Receives: Behavioral: Antimicrobial and PPI Stewardship Program; Behavioral: Standard Bathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From ICU admission up to ICU discharge (an average of 10-14 days)
Secondary outcomes (4)
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.
Measured: 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:
- Colorimetric CHG skin concentration testing, with adherence defined as CHG concentration ≥125 µg/mL on at least 2 of 3 body sites;
- Chlorhexidine Bathing Checklist completed by bedside staff; and
- 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.
Measured: 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.
Measured: 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.
Measured: Monthly, from intervention start (Month 1) to study end (Month 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start14 Jul 2025
- Primary completion14 Jul 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Carbapenemase-Producing Enterobacteriaceae (CPE)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Cluster-randomized crossover trial involving six intensive care units (ICUs) across three university-affiliated hospitals. Each hospital contributes two ICUs, which are randomized to either the intervention or control group for six months, followed by crossover to the opposite group.
- Masking
- None (open label)
- Enrolment
- 5,760 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chuncheon Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Wonju Severance Christian Hospital, Gangneung Asan Hospital, National Institute of Health, Korea
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07039955
- Sponsor's protocol ID
- 2025-05-001
- Status last verified
- Jun 2025
- First submitted
- 6 Jun 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy concerns and the nature of the cluster-level intervention design.
Publications
Rhee Y, Hayden MK, Schoeny M, Baker AW, Baker MA, Gohil S, Rhee C, Talati NJ, Warren DK, Welbel S, Lolans K, Bahadori B, Bell PB, Bravo H, Dangana T, Fukuda C, Habrock Bach T, Nelson A, Simms AT, Tolomeo P, Wolf R, Yelin R, Lin MY; CDC Prevention Epicenters Program. Impact of measurement and feedback on chlorhexidine gluconate bathing among intensive care unit patients: A multicenter study. Infect Control Hosp Epidemiol. 2023 Sep;44(9):1375-1380. doi: 10.1017/ice.2023.177. Epub 2023 Sep 13.
PubMed 37700540Willems RPJ, van Dijk K, Ket JCF, Vandenbroucke-Grauls CMJE. Evaluation of the Association Between Gastric Acid Suppression and Risk of Intestinal Colonization With Multidrug-Resistant Microorganisms: A Systematic Review and Meta-analysis. JAMA Intern Med. 2020 Apr 1;180(4):561-571. doi: 10.1001/jamainternmed.2020.0009.
PubMed 32091544Rhee Y, Simms AT, Schoeny M, Baker AW, Baker MA, Gohil S, Rhee C, Talati NJ, Warren DK, Welbel S, Lolans K, Bell PB, Fukuda C, Hayden MK, Lin MY; CDC Prevention Epicenters Program. Relationship between chlorhexidine gluconate concentration and microbial colonization of patients' skin. Infect Control Hosp Epidemiol. 2024 Sep;45(9):1079-1084. doi: 10.1017/ice.2024.81. Epub 2024 May 28.
PubMed 38804007Patel A, Parikh P, Dunn AN, Otter JA, Thota P, Fraser TG, Donskey CJ, Deshpande A. Effectiveness of daily chlorhexidine bathing for reducing gram-negative infections: A meta-analysis. Infect Control Hosp Epidemiol. 2019 Apr;40(4):392-399. doi: 10.1017/ice.2019.20. Epub 2019 Feb 26.
PubMed 30803462Climo MW, Yokoe DS, Warren DK, Perl TM, Bolon M, Herwaldt LA, Weinstein RA, Sepkowitz KA, Jernigan JA, Sanogo K, Wong ES. Effect of daily chlorhexidine bathing on hospital-acquired infection. N Engl J Med. 2013 Feb 7;368(6):533-42. doi: 10.1056/NEJMoa1113849.
PubMed 23388005
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Daily Chlorhexidine Bathing and Antibiotic and Proton Pump Inhibitor (PPI) Stewardship in Preventing Transmission and Infection Caused by Carbapenemase-Producing Enterobacteriaceae (CPE)
- ClinicalTrials.gov ID
- NCT07039955
- Acronym / sponsor ID
- 2025-05-001
- Keywords
- Carbapenemase-Producing Enterobacteriaceae, Healthcare-Associated Infections, Intensive Care Unit, infection control, Daily Chlorhexidine Bathing, Antimicrobial Stewardship, Proton Pump Inhibitor Stewardship, Chlorhexidine (CHG) Skin Concentration
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 5,760 participants (estimated)
- Lead sponsor
- Chuncheon Sacred Heart HospitalUniversity, hospital or other
- Collaborators
- Wonju Severance Christian Hospital, Gangneung Asan Hospital, National Institute of Health, Korea
- Study start
- 14 Jul 2025 (actual)
- Primary completion
- 14 Jul 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 26 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Assessment of residual CHG skin concentrations at 3-month intervals using standardized skin swabs and comparison of these concentrations with the minimum inhibitory concentrations (MICs) of CPE isolates obtained from clinical and surveillance cultures to evaluate the adequacy of chlorhexidine exposure.
- Evaluation of adherence to CHG bathing protocols through quarterly feedback of CHG skin concentration results to ICU staff.
- Assessment of adverse skin reactions associated with CHG bathing to evaluate its safety in critically ill patients.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster-randomized crossover trial involving six intensive care units (ICUs) across three university-affiliated hospitals. Each hospital contributes two ICUs, which are randomized to either the intervention or control group for six months, followed by crossover to the opposite group.
| Arm | Type | Receives |
|---|---|---|
| CHG Bathing + Antimicrobial/PPI Stewardship | Experimental | Behavioral: Daily Chlorhexidine Bathing, Behavioral: Antimicrobial and PPI Stewardship ProgramPatients 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. |
| Standard Bathing + Antimicrobial/PPI Stewardship | Active comparator | Behavioral: Antimicrobial and PPI Stewardship Program, Behavioral: Standard BathingPatients 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 19 years or older
- Admitted to one of the participating intensive care units (ICUs):
Key exclusion criteria (3 listed)
- Age 18 years or younger
- Patients with extensive burns
- Patients with a known hypersensitivity to chlorhexidine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daily Chlorhexidine BathingDaily 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. | Behavioural | CHG Bathing + Antimicrobial/PPI Stewardship |
| Antimicrobial and PPI Stewardship ProgramA 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. | Behavioural | CHG Bathing + Antimicrobial/PPI Stewardship, Standard Bathing + Antimicrobial/PPI Stewardship |
| Standard BathingPatients 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. | Behavioural | Standard Bathing + Antimicrobial/PPI Stewardship |
Primary outcome
Incidence of CPE Colonization and Infection
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.
4 secondary outcomes
Residual CHG Skin Concentration vs. CPE MIC Comparison
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
Time frame: Approximately Day 15 of Months 0, 3, and 6 during the intervention period
Incidence of Adverse Skin Reactions Related to CHG Bathing
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
Time frame: Monthly, from intervention start (Month 1) to study end (Month 12)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Background: PubMed 37700540Rhee Y, Hayden MK, Schoeny M, Baker AW, Baker MA, Gohil S, Rhee C, Talati NJ, Warren DK, Welbel S, Lolans K, Bahadori B, Bell PB, Bravo H, Dangana T, Fukuda C, Habrock Bach T, Nelson A, Simms AT, Tolomeo P, Wolf R, Yelin R, Lin MY; CDC Prevention Epicenters Program. Impact of measurement and feedback on chlorhexidine gluconate bathing among intensive care unit patients: A multicenter study. Infect Control Hosp Epidemiol. 2023 Sep;44(9):1375-1380. doi: 10.1017/ice.2023.177. Epub 2023 Sep 13.
- Background: PubMed 32091544Willems RPJ, van Dijk K, Ket JCF, Vandenbroucke-Grauls CMJE. Evaluation of the Association Between Gastric Acid Suppression and Risk of Intestinal Colonization With Multidrug-Resistant Microorganisms: A Systematic Review and Meta-analysis. JAMA Intern Med. 2020 Apr 1;180(4):561-571. doi: 10.1001/jamainternmed.2020.0009.
- Background: PubMed 38804007Rhee Y, Simms AT, Schoeny M, Baker AW, Baker MA, Gohil S, Rhee C, Talati NJ, Warren DK, Welbel S, Lolans K, Bell PB, Fukuda C, Hayden MK, Lin MY; CDC Prevention Epicenters Program. Relationship between chlorhexidine gluconate concentration and microbial colonization of patients' skin. Infect Control Hosp Epidemiol. 2024 Sep;45(9):1079-1084. doi: 10.1017/ice.2024.81. Epub 2024 May 28.
- Background: PubMed 30803462Patel A, Parikh P, Dunn AN, Otter JA, Thota P, Fraser TG, Donskey CJ, Deshpande A. Effectiveness of daily chlorhexidine bathing for reducing gram-negative infections: A meta-analysis. Infect Control Hosp Epidemiol. 2019 Apr;40(4):392-399. doi: 10.1017/ice.2019.20. Epub 2019 Feb 26.
- Background: PubMed 23388005Climo MW, Yokoe DS, Warren DK, Perl TM, Bolon M, Herwaldt LA, Weinstein RA, Sepkowitz KA, Jernigan JA, Sanogo K, Wong ES. Effect of daily chlorhexidine bathing on hospital-acquired infection. N Engl J Med. 2013 Feb 7;368(6):533-42. doi: 10.1056/NEJMoa1113849.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy concerns and the nature of the cluster-level intervention design.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily Chlorhexidine Bathing, Antimicrobial and PPI Stewardship Program and Standard Bathing in people with Carbapenemase-Producing Enterobacteriaceae (CPE) and Healthcare-Associated Infections (HAIs), run by Chuncheon Sacred Heart Hospital at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of CPE Colonization and Infection (time frame: From ICU admission up to ICU discharge (an average of 10-14 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07039955, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.