NCT03639363

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
449

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2015

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 10, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2016

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2016

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 13, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 21, 2018

Completed
Last Updated

August 21, 2018

Status Verified

August 1, 2018

Enrollment Period

9 months

First QC Date

August 13, 2018

Last Update Submit

August 17, 2018

Conditions

Hospital Infection

Keywords

4% chlorhexidine gluconateinfection control

Outcome Measures

Primary Outcomes (1)

  • 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)

    infections occured 48 hours after admission to ICU/PC-ICU

Secondary Outcomes (8)

  • Ventilator-associated pnemonias (VAP) incidence

    infections occured 48 hours after admission to ICU/PC-ICU

  • Bloodstream infections (BSI) incidence

    infections occured 48 hours after admission to ICU/PC-ICU

  • central-line associated BSI (CLABSI) incidence

    infections occured 48 hours after admission to ICU/PC-ICU

  • urinary tract infections (UTI) incidence

    infections occured 48 hours after admission to ICU/PC-ICU

  • catheter associated UTI (CAUTI) incidence

    infections occured 48 hours after admission to ICU/PC-ICU

  • +3 more secondary outcomes

Study Arms (2)

Intervention Arm

EXPERIMENTAL

daily bathing with 4% chlorhexidine gluconate soap-like solution followed by water rinsing

Drug: 4% chlorhexidine gluconate soap-like solution

Control Arm

ACTIVE COMPARATOR

daily bathing with standard soap

Other: standard soap

Interventions

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

Intervention Arm
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

Control Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 30267930DERIVED

MeSH Terms

Conditions

Cross Infection

Condition Hierarchy (Ancestors)

InfectionsIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • franco baldelli, Professor

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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor, Principal investigator

Study Record Dates

First Submitted

August 13, 2018

First Posted

August 21, 2018

Study Start

August 10, 2015

Primary Completion

April 28, 2016

Study Completion

May 2, 2016

Last Updated

August 21, 2018

Record last verified: 2018-08