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

Impact of Chlorhexidine Bath on Healthcare-associated Infections Acquisitions in Intensive Care Units - A Cluster Randomized Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Ventilator Associated Pneumonia; Health Care Associated Infection; Catheter-Associated Urinary Tract Infection; Central Line-associated Bloodstream Infection (CLABSI)
• Intervention / Treatment: Other: 2% chlorhexidine digluconate solution with surface-active agents; Other: Usual Baths

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.

• Study Type: Interventional
• Enrollment (Estimated): 12600
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Bruno M Tomazini, M.D; Phone Number: +55113053-6611; Email: btomazini@hcor.com.br
• Study Contact Backup: Name: Alexandre B. Cavalcanti, M.D; Phone Number: +55113053-6611; Email: abiasi@hcor.com.br

Study Locations

• Brazil
  • Rio De Janeiro, Brazil
    • Hospital Naval Marcílio Dias
  • São Paulo, Brazil
    • BP-A Beneficiência Portuguesa de São Paulo
  • São Paulo, Brazil
    • AC Camargo Câncer Center
  • BA
    • Salvador, BA, Brazil
      • Hospital da Cidade
    • Salvador, BA, Brazil
      • Hospital da Bahia
  • DF
    • Brasília, DF, Brazil
      • Hospital Universitário de Brasília
  • ES
    • Colatina, ES, Brazil
      • Hospital Maternidade São José - UNESC - Fundação Social Rural de Colatina
  • PA
    • Santarém, PA, Brazil
      • Hospital Regional do Baixo Amazonas Dr. Waldemar Penna
  • PE
    • Recife, PE, Brazil
      • Hospital das Clínicas da Universidade Federal de Pernambuco
  • PR
    • Maringá, PR, Brazil
      • Hospital Municipal de Maringá
  • RS
    • Caxias do Sul, RS, Brazil
      • Hospital Geral de Caxias do Sul
    • Santa Cruz do Sul, RS, Brazil
      • Hospital Santa Cruz
  • SC
    • Florianópolis, SC, Brazil
      • Instituto Baía Sul de Ensino e Pesquisa Irineu May Brodbeck
  • SE
    • Aracaju, SE, Brazil
      • Hospital sao lucas
  • SP
    • São Paulo, SP, Brazil
      • Hospital Aviccena
  • Sc
    • Florianópolis, Sc, Brazil
      • Hospital Nereu Ramos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• History of chlorhexidine allergy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chlorhexidine baths; 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.	Other: 2% chlorhexidine digluconate solution with surface-active agents; 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.; Other Names: Chlorhexidine baths
Active Comparator: Usual baths; 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.	Other: Usual Baths; 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.; Other Names: Soap and water baths

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Within each cluster duration (90 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of multi-drug-resistant pathogens	Rates of positive clinical microbiological cultures (colonization and infection) by multi-drug-resistant (MDR) pathogens.	Within each cluster duration (90 days)
Ventilator associated pneumonia (VAP)	Rates of Ventilator associated pneumonia (VAP)	Within each cluster duration (90 days)
Central line-associated blood stream infections (CLABSI)	Rates of Central line-associated blood stream infections (CLABSI)	Within each cluster duration (90 days)
Catheter-associated urinary tract infection (CAUTI)	Rates of Catheter-associated urinary tract infection (CAUTI)	Within each cluster duration (90 days)
Hospital length of stay	Hospital length of stay	Until hospital discharge, maximum 90 days
Intensive Care Unit length of stay	Intensive Care Unit length of stay	Until Intensive Care Unit discharge, maximum 90 days
Antibiotic use	Antibiotic use per unit	Within each cluster duration (90 days)
In hospital mortality	In hospital mortality	Maximum 90 days after randomization
Intensive Care Unit mortality	Intensive Care Unit mortality	Maximum 90 days after randomization

Collaborators and Investigators

• Sponsor: Hospital do Coracao
• Collaborators: Hospital Israelita Albert Einstein; Hospital Moinhos de Vento; Hospital Sirio-Libanes; Hospital Alemão Oswaldo Cruz; A Beneficência Portuguesa de São Paulo
• Investigators: Principal Investigator: Bruno M Tomazini, M.D, btomazini@hcor.com.br; Study Director: Alexandre B Cavalcanti, M.D, HCor Research Institute Director

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2022
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: July 28, 2022
• First Submitted That Met QC Criteria: July 31, 2022
• First Posted (Actual): August 2, 2022

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia; Lung Diseases; Urologic Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Disease Attributes; Iatrogenic Disease; Healthcare-Associated Pneumonia; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Sepsis; Infections; Communicable Diseases; Urinary Tract Infections; Pneumonia, Ventilator-Associated; Cross Infection; Anti-Infective Agents, Local; Anti-Infective Agents; Dermatologic Agents; Disinfectants; Chlorhexidine; Chlorhexidine gluconate
• Other Study ID Numbers: ip_hcor_cleanit

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No