4% Chlorhexidine Gluconate Daily Bathing for Prevention of Hospital-acquired Infections in Intensive Care Settings (Duclorexint)
August 17, 2018 updated by: Carlo Pallotto, University Of Perugia
Study on the Effect of the Universal Decontamination With Daily Bathing With 4% Chlorhexidine Gluconate on the Incidence of Hospital Acquired Infections in Intensive Care Units
The study will assess the utility of 4% chlorhexidine gluconate (CHG) daily bathing to reduce hospital acquired infections in patients admitted to intensive care units.
One group will be daily bathed with 4% CHG and the other group with standard soap.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
449
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- admission to the intensive care unit (ICU) or to the post-operative cardiosurgical ICU (PC-ICU)
- ICU/PC-ICU stay for at least 1 night
Exclusion Criteria:
- known allergy to chlorhexidine
- burns, toxic epidermal necrolysis or Stevens-Johnson syndrome as admission diagnosis
- pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Arm
daily bathing with 4% chlorhexidine gluconate soap-like solution followed by water rinsing
|
|
|
Active Comparator: Control Arm
daily bathing with standard soap
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
hospital acquired infections incidence
Time Frame: infections occured 48 hours after admission to ICU/PC-ICU
|
cumulative incidence of bloodstream infections (BSI), central line-associates BSI (CLABSI), urinary tract infections (UTI), catheter-associated UTI (CAUTI) and ventilator-associated pneumonias (VAP)
|
infections occured 48 hours after admission to ICU/PC-ICU
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ventilator-associated pnemonias (VAP) incidence
Time Frame: infections occured 48 hours after admission to ICU/PC-ICU
|
VAP incidence
|
infections occured 48 hours after admission to ICU/PC-ICU
|
|
Bloodstream infections (BSI) incidence
Time Frame: infections occured 48 hours after admission to ICU/PC-ICU
|
BSI incidence
|
infections occured 48 hours after admission to ICU/PC-ICU
|
|
central-line associated BSI (CLABSI) incidence
Time Frame: infections occured 48 hours after admission to ICU/PC-ICU
|
CLABSI incidence
|
infections occured 48 hours after admission to ICU/PC-ICU
|
|
urinary tract infections (UTI) incidence
Time Frame: infections occured 48 hours after admission to ICU/PC-ICU
|
UTI incidence
|
infections occured 48 hours after admission to ICU/PC-ICU
|
|
catheter associated UTI (CAUTI) incidence
Time Frame: infections occured 48 hours after admission to ICU/PC-ICU
|
CAUTI incidence
|
infections occured 48 hours after admission to ICU/PC-ICU
|
|
4% CHG daily bathing safety
Time Frame: at discharge, approximately up to 10 days
|
overall mortality in the treatment and control arm
|
at discharge, approximately up to 10 days
|
|
4% CHG daily bathing-related adverse events
Time Frame: at discharge, approximately up to 10 days
|
4% CHG daily bathing-related adverse events in the treatment arm compared to standard soap-related adverse events
|
at discharge, approximately up to 10 days
|
|
time till infection
Time Frame: at discharge, approximately up to 10 days
|
time between admission to ICU/PC-ICU and infection occurrence
|
at discharge, approximately up to 10 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: franco baldelli, Professor, Infectious Diseases Clinical, University Hospital of Perugia, Perugia, Italy
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 10, 2015
Primary Completion (Actual)
April 28, 2016
Study Completion (Actual)
May 2, 2016
Study Registration Dates
First Submitted
August 13, 2018
First Submitted That Met QC Criteria
August 17, 2018
First Posted (Actual)
August 21, 2018
Study Record Updates
Last Update Posted (Actual)
August 21, 2018
Last Update Submitted That Met QC Criteria
August 17, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Duclorexint
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.