Hospital InfectionPhase 4DuclorexintNCT03639363

4% Chlorhexidine Gluconate Daily Bathing for Prevention of Hospital-acquired Infections in Intensive Care Settings

A Phase 4 study testing 4% chlorhexidine gluconate soap-like solution and standard soap in people with Hospital Infection, run by University Of Perugia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hospital Infection
What is being tested?: 4% chlorhexidine gluconate soap-like solution and standard soap
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 449 participants
Where: No sites listed yet
Study dates: 10 Aug 2015to 2 May 2016
Phase: Phase 4
Are there results?: None posted in the registry

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

known allergy to chlorhexidine
burns, toxic epidermal necrolysis or Stevens-Johnson syndrome as admission diagnosis
pregnancy

About this study

Official title: 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

Conditions: Hospital Infection
Being tested: 4% chlorhexidine gluconate soap-like solution, standard soap
Keywords: 4% chlorhexidine gluconate, infection control
Medical subject headings: Cross Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

4% chlorhexidine gluconate soap-like solutionDrug
1. humidify the whole body surface with the exception of the face using water-impregnated washcloths
2. use 4% CHG-impregnated washcloths to bath the whole body surface with the exception of the face; use at least 30 ml of 4% CHG
3. wait for at least 30 seconds
4. rinse using water-impregnated washcloths
standard soapOther
1. humidify the whole body surface with the exception of the face using water-impregnated washcloths
2. use standard soap-impregnated washcloths to bath the whole body surface with the exception of the face
3. wait for at least 30 seconds
4. rinse using water-impregnated washcloths

Study groups in NCT03639363
Study group	Role	What they receive
Intervention Arm	Experimental	daily bathing with 4% chlorhexidine gluconate soap-like solution followed by water rinsing Receives: Drug: 4% chlorhexidine gluconate soap-like solution
Control Arm	Active comparator	daily bathing with standard soap Receives: Other: standard soap

What is being measured

The primary outcome is the main question the study is designed to answer.

hospital acquired infections incidence
cumulative incidence of bloodstream infections (BSI), central line-associates BSI (CLABSI), urinary tract infections (UTI), catheter-associated UTI (CAUTI) and ventilator-associated pneumonias (VAP)
Measured: infections occured 48 hours after admission to ICU/PC-ICU

Secondary outcomes (8)

Ventilator-associated pnemonias (VAP) incidence
VAP incidence
Measured: infections occured 48 hours after admission to ICU/PC-ICU
Bloodstream infections (BSI) incidence
BSI incidence
Measured: infections occured 48 hours after admission to ICU/PC-ICU
central-line associated BSI (CLABSI) incidence
CLABSI incidence
Measured: infections occured 48 hours after admission to ICU/PC-ICU
urinary tract infections (UTI) incidence
UTI incidence
Measured: infections occured 48 hours after admission to ICU/PC-ICU
catheter associated UTI (CAUTI) incidence
CAUTI incidence
Measured: infections occured 48 hours after admission to ICU/PC-ICU
4% CHG daily bathing safety
overall mortality in the treatment and control arm
Measured: at discharge, approximately up to 10 days
4% CHG daily bathing-related adverse events
4% CHG daily bathing-related adverse events in the treatment arm compared to standard soap-related adverse events
Measured: at discharge, approximately up to 10 days
time till infection
time between admission to ICU/PC-ICU and infection occurrence
Measured: at discharge, approximately up to 10 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Aug 20152 May 2016

First posted21 Aug 2018
Study start10 Aug 2015
Primary completion28 Apr 2016
Study completion2 May 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Hospital InfectionStudies 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 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 449 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03639363
Sponsor's protocol ID: Duclorexint
Acronym: Duclorexint
Status last verified: Aug 2018
First submitted: 13 Aug 2018
Last updated: 21 Aug 2018
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Pallotto C, Fiorio M, De Angelis V, Ripoli A, Franciosini E, Quondam Girolamo L, Volpi F, Iorio P, Francisci D, Tascini C, Baldelli F. Daily bathing with 4% chlorhexidine gluconate in intensive care settings: a randomized controlled trial. Clin Microbiol Infect. 2019 Jun;25(6):705-710. doi: 10.1016/j.cmi.2018.09.012. Epub 2018 Sep 26.
PubMed 30267930

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Hospital Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT03639363
Acronym / sponsor ID: Duclorexint / Duclorexint
Conditions: Hospital Infection
Keywords: 4% chlorhexidine gluconate, infection control
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 449 participants (actual)
Lead sponsor: University Of PerugiaUniversity, hospital or other
Collaborators: Fondazione Toscana Gabriele Monasterio
Study start: 10 Aug 2015 (actual)
Primary completion: 28 Apr 2016 (actual)
Study completion: 2 May 2016 (actual)
First posted: 21 Aug 2018 (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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Intervention Arm	Experimental	Drug: 4% chlorhexidine gluconate soap-like solutiondaily bathing with 4% chlorhexidine gluconate soap-like solution followed by water rinsing
Control Arm	Active comparator	Other: standard soapdaily bathing with standard soap

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (3 listed)

known allergy to chlorhexidine
burns, toxic epidermal necrolysis or Stevens-Johnson syndrome as admission diagnosis
pregnancy

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
4% chlorhexidine gluconate soap-like solution1. humidify the whole body surface with the exception of the face using water-impregnated washcloths 2. use 4% CHG-impregnated washcloths to bath the whole body surface with the exception of the face; use at least 30 ml of 4% CHG 3. wait for at least 30 seconds 4. rinse using water-impregnated washcloths	Drug	Intervention Arm
standard soap1. humidify the whole body surface with the exception of the face using water-impregnated washcloths 2. use standard soap-impregnated washcloths to bath the whole body surface with the exception of the face 3. wait for at least 30 seconds 4. rinse using water-impregnated washcloths	Other	Control Arm

Primary outcome

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)

8 secondary outcomes

Ventilator-associated pnemonias (VAP) incidence
Time frame: 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
central-line associated BSI (CLABSI) incidence
Time frame: 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
catheter associated UTI (CAUTI) incidence
Time frame: infections occured 48 hours after admission to ICU/PC-ICU
4% CHG daily bathing safety
Time frame: at discharge, approximately up to 10 days
4% CHG daily bathing-related adverse events
Time frame: at discharge, approximately up to 10 days
time till infection
Time frame: at discharge, approximately up to 10 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2018.
Derived from this study: PubMed 30267930Pallotto C, Fiorio M, De Angelis V, Ripoli A, Franciosini E, Quondam Girolamo L, Volpi F, Iorio P, Francisci D, Tascini C, Baldelli F. Daily bathing with 4% chlorhexidine gluconate in intensive care settings: a randomized controlled trial. Clin Microbiol Infect. 2019 Jun;25(6):705-710. doi: 10.1016/j.cmi.2018.09.012. Epub 2018 Sep 26.

Related trials for Hospital Infection

Not yet recruiting
HAIQU (Hospital AIr QUality)
Acute Respiratory Tract Infection
Not yet recruitingObservational study
Traditional Chinese Medicine in Multidrug-Resistant Bacterial Pneumonia
Multi Drug Resistant Infections, Pneumnia
RecruitingObservational study
POS-ARI-ER Observational Study of Acute Respiratory Infections
Acute Respiratory Infection, Acute Respiratory Tract Infection
Recruiting
Polypharmacy on Healthy Aging in People Living With HIV Over the Age of 75
Virus-HIV
Recruiting
RSV Burden in Outpatient and Hospital Settings
RSV Infection, Children, Only

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. This study is not recruiting at the moment.

franco baldelli, Professor study chair

Infectious Diseases Clinical, University Hospital of Perugia, Perugia, Italy

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 4% chlorhexidine gluconate soap-like solution and standard soap in people with Hospital Infection, run by University Of Perugia.

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 2 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: finished, as of the sponsor's last update on 21 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

hospital acquired infections incidence (time frame: infections occured 48 hours after admission to ICU/PC-ICU). 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 NCT03639363, which also lists 1 linked publication.

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 21 Aug 2018.