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Daily Chlorexidine Bath for Health Care Associated Infection Prevention (CLEAN-IT)

Primary Purpose

Health Care Associated Infection, Ventilator Associated Pneumonia, Central Line-associated Bloodstream Infection (CLABSI)

Status
Recruiting
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
2% chlorhexidine digluconate solution with surface-active agents
Usual Baths
Sponsored by
Hospital do Coracao
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Health Care Associated Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients ≥ 18 years/old admitted to the participants's ICUs

Exclusion Criteria:

  • History of chlorhexidine allergy

Sites / Locations

  • Hospital da Bahia
  • Hospital da Cidade
  • Hospital Universitário de Brasília
  • Hospital Maternidade São José - UNESC - Fundação Social Rural de Colatina
  • Hospital Regional do Baixo Amazonas Dr. Waldemar Penna
  • Hospital das Clínicas da Universidade Federal de Pernambuco
  • Hospital Municipal de Maringá
  • Hospital Geral de Caxias do Sul
  • Hospital Santa Cruz
  • Hospital Nereu Ramos
  • Instituto Baía Sul de Ensino e Pesquisa Irineu May Brodbeck
  • Hospital São Lucas
  • Hospital Aviccena
  • Hospital Naval Marcílio DiasRecruiting
  • AC Camargo Câncer Center
  • BP-A Beneficiência Portuguesa de São PauloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Chlorhexidine baths

Usual baths

Arm Description

All patients in the cluster randomized to the intervention arm will receive baths using a 2% chlorhexidine digluconate solution with surface-active agents during the intervention period. All other infection control and cleaning procedures will be performed according to the current practice in each center.

All patients in the cluster randomized to the intervention arm will receive baths using soap and water according to the current practice in each center during the intervention period. All other infection control and cleaning procedures will be performed according to the current practice in each center.

Outcomes

Primary Outcome Measures

Composite of healthcare-associated infections (HAI)
Composite outcome of the following HAI: Ventilator associated pneumonia (VAP) Central line-associated blood stream infections (CLABSI) Catheter-associated urinary tract infection (CAUTI)

Secondary Outcome Measures

Rates of multi-drug-resistant pathogens
Rates of positive clinical microbiological cultures (colonization and infection) by multi-drug-resistant (MDR) pathogens.
Ventilator associated pneumonia (VAP)
Rates of Ventilator associated pneumonia (VAP)
Central line-associated blood stream infections (CLABSI)
Rates of Central line-associated blood stream infections (CLABSI)
Catheter-associated urinary tract infection (CAUTI)
Rates of Catheter-associated urinary tract infection (CAUTI)
Hospital length of stay
Hospital length of stay
Intensive Care Unit length of stay
Intensive Care Unit length of stay
Antibiotic use
Antibiotic use per unit
In hospital mortality
In hospital mortality
Intensive Care Unit mortality
Intensive Care Unit mortality

Full Information

First Posted
July 28, 2022
Last Updated
September 21, 2022
Sponsor
Hospital do Coracao
Collaborators
Hospital Sírio-Libanês, Hospital Israelita Albert Einstein, Hospital Moinhos de Vento, Hospital Alemão Oswaldo Cruz, A Beneficência Portuguesa de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT05485051
Brief Title
Daily Chlorexidine Bath for Health Care Associated Infection Prevention
Acronym
CLEAN-IT
Official Title
Impact of Chlorhexidine Bath on Healthcare-associated Infections Acquisitions in Intensive Care Units - A Cluster Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 3, 2022 (Actual)
Primary Completion Date
December 10, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital do Coracao
Collaborators
Hospital Sírio-Libanês, Hospital Israelita Albert Einstein, Hospital Moinhos de Vento, Hospital Alemão Oswaldo Cruz, A Beneficência Portuguesa de São Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Cluster randomized controlled trial comparing two bathing strategies in critically ill patients. The intervention group will receive daily bathing with chlorhexidine. The control group will receive usual care.
Detailed Description
Healthcare-associated infections (HAI) are common complications in critically ill patients and are associated with increased costs, higher length of stay, and higher morbimortality. Data shows that daily chlorhexidine baths might be associated with lower HAI rates in a broad population of critically ill patients. The purpose of this trial is to evaluate the effect of daily bathing with chlorhexidine compared to usual baths (soap and water) on HAI in critically ill patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Health Care Associated Infection, Ventilator Associated Pneumonia, Central Line-associated Bloodstream Infection (CLABSI), Catheter-Associated Urinary Tract Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Model Description
The study consists in two intervention (chlorhexidine baths) periods (three months each period) and two control (usual baths) periods (three months each period) for each cluster. The clusters will crossover between intervention and control with one month of washout period between different periods.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chlorhexidine baths
Arm Type
Experimental
Arm Description
All patients in the cluster randomized to the intervention arm will receive baths using a 2% chlorhexidine digluconate solution with surface-active agents during the intervention period. All other infection control and cleaning procedures will be performed according to the current practice in each center.
Arm Title
Usual baths
Arm Type
Active Comparator
Arm Description
All patients in the cluster randomized to the intervention arm will receive baths using soap and water according to the current practice in each center during the intervention period. All other infection control and cleaning procedures will be performed according to the current practice in each center.
Intervention Type
Other
Intervention Name(s)
2% chlorhexidine digluconate solution with surface-active agents
Other Intervention Name(s)
Chlorhexidine baths
Intervention Description
Bathing will be performed at least daily using 2% chlorhexidine digluconate solution with surface-active agents on all applicable bathing surfaces, which consists of the entire body surface of the patient except eyes, inner ear, oral mucosa, and areas of loss of skin continuity (such as burnt areas, pressure injuries, etc.); These areas will be bathed according to each center current practice.
Intervention Type
Other
Intervention Name(s)
Usual Baths
Other Intervention Name(s)
Soap and water baths
Intervention Description
Bathing will be performed at least daily using soap and water (performed according to the current practice in each center) on all applicable bathing surfaces, which consists of the entire body surface of the patient except eyes, inner ear, oral mucosa, and areas of loss of skin continuity (such as burnt areas, pressure injuries, etc.); These areas will be bathed according to each center current practice.
Primary Outcome Measure Information:
Title
Composite of healthcare-associated infections (HAI)
Description
Composite outcome of the following HAI: Ventilator associated pneumonia (VAP) Central line-associated blood stream infections (CLABSI) Catheter-associated urinary tract infection (CAUTI)
Time Frame
Within each cluster duration (90 days)
Secondary Outcome Measure Information:
Title
Rates of multi-drug-resistant pathogens
Description
Rates of positive clinical microbiological cultures (colonization and infection) by multi-drug-resistant (MDR) pathogens.
Time Frame
Within each cluster duration (90 days)
Title
Ventilator associated pneumonia (VAP)
Description
Rates of Ventilator associated pneumonia (VAP)
Time Frame
Within each cluster duration (90 days)
Title
Central line-associated blood stream infections (CLABSI)
Description
Rates of Central line-associated blood stream infections (CLABSI)
Time Frame
Within each cluster duration (90 days)
Title
Catheter-associated urinary tract infection (CAUTI)
Description
Rates of Catheter-associated urinary tract infection (CAUTI)
Time Frame
Within each cluster duration (90 days)
Title
Hospital length of stay
Description
Hospital length of stay
Time Frame
Until hospital discharge, maximum 90 days
Title
Intensive Care Unit length of stay
Description
Intensive Care Unit length of stay
Time Frame
Until Intensive Care Unit discharge, maximum 90 days
Title
Antibiotic use
Description
Antibiotic use per unit
Time Frame
Within each cluster duration (90 days)
Title
In hospital mortality
Description
In hospital mortality
Time Frame
Maximum 90 days after randomization
Title
Intensive Care Unit mortality
Description
Intensive Care Unit mortality
Time Frame
Maximum 90 days after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients ≥ 18 years/old admitted to the participants's ICUs Exclusion Criteria: History of chlorhexidine allergy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bruno M Tomazini, M.D
Phone
+55113053-6611
Email
btomazini@hcor.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandre B. Cavalcanti, M.D
Phone
+55113053-6611
Email
abiasi@hcor.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno M Tomazini, M.D
Organizational Affiliation
btomazini@hcor.com.br
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alexandre B Cavalcanti, M.D
Organizational Affiliation
HCor Research Institute Director
Official's Role
Study Director
Facility Information:
Facility Name
Hospital da Bahia
City
Salvador
State/Province
BA
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marianna Deway Andrade Dracoulakis
Facility Name
Hospital da Cidade
City
Salvador
State/Province
BA
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andre Gobato
Facility Name
Hospital Universitário de Brasília
City
Brasília
State/Province
DF
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valéria Paes Lima Fernandes
Facility Name
Hospital Maternidade São José - UNESC - Fundação Social Rural de Colatina
City
Colatina
State/Province
ES
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodrigo Cruvinel
Facility Name
Hospital Regional do Baixo Amazonas Dr. Waldemar Penna
City
Santarém
State/Province
PA
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Carlos Alves da Silva
Facility Name
Hospital das Clínicas da Universidade Federal de Pernambuco
City
Recife
State/Province
PE
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudia Fernanda de Lacerda Vidal
Facility Name
Hospital Municipal de Maringá
City
Maringá
State/Province
PR
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francielle Constantino Pereira
Facility Name
Hospital Geral de Caxias do Sul
City
Caxias do Sul
State/Province
RS
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emerson Silva
Facility Name
Hospital Santa Cruz
City
Santa Cruz do Sul
State/Province
RS
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rafael Foernges
Facility Name
Hospital Nereu Ramos
City
Florianópolis
State/Province
Sc
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Israel Maia, PhD
Email
israels.maia@gmail.com ;
Facility Name
Instituto Baía Sul de Ensino e Pesquisa Irineu May Brodbeck
City
Florianópolis
State/Province
SC
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Israel S Maia
Facility Name
Hospital São Lucas
City
Aracaju
State/Province
SE
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberta Machado de Souza
Facility Name
Hospital Aviccena
City
São Paulo
State/Province
SP
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silvia Regina de Mello Nasareth
Facility Name
Hospital Naval Marcílio Dias
City
Rio De Janeiro
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vicente Dantas
Email
vicentecsdantas@gmail.com
Facility Name
AC Camargo Câncer Center
City
São Paulo
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paulo Nassar, MD, PhD
Facility Name
BP-A Beneficiência Portuguesa de São Paulo
City
São Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Viviane Veiga
Email
dveiga@uol.com.br

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
1 year after publication of primary results
IPD Sharing Access Criteria
Submission of a statistical analysis plan for the purposed analyses. Compliance with Brazilian. Data privacy law.

Learn more about this trial

Daily Chlorexidine Bath for Health Care Associated Infection Prevention

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