Daily Chlorexidine Bath for Health Care Associated Infection Prevention

NCT05485051 | Completed Phase 3

• 1 other identifier: ip_hcor_cleanit
• Study Type: interventional
• Target: 15,730
• Locations: 1 country
• Sites: 16

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.

Conditions

Health Care Associated Infection; Ventilator Associated Pneumonia; Central Line-associated Bloodstream Infection (CLABSI); Catheter-Associated Urinary Tract Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Rates of multi-drug-resistant pathogens

  Within each cluster duration (90 days)

• Ventilator associated pneumonia (VAP)

  Within each cluster duration (90 days)

• Central line-associated blood stream infections (CLABSI)

  Within each cluster duration (90 days)

• Catheter-associated urinary tract infection (CAUTI)

  Within each cluster duration (90 days)

• Hospital length of stay

  Until hospital discharge, maximum 90 days

Study Arms (2)

Chlorhexidine baths

EXPERIMENTAL

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

Usual baths

ACTIVE COMPARATOR

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

Interventions

2% chlorhexidine digluconate solution with surface-active agents OTHER

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.

Also known as: Chlorhexidine baths

Chlorhexidine baths

Usual Baths OTHER

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.

Also known as: Soap and water baths

Usual baths

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• History of chlorhexidine allergy

Sponsors & Collaborators

• Hospital do Coracao: lead
• Hospital Sírio-Libanês: collaborator
• Hospital Israelita Albert Einstein: collaborator
• Hospital Moinhos de Vento: collaborator
• Hospital Alemão Oswaldo Cruz: collaborator
• A Beneficência Portuguesa de São Paulo: collaborator

Study Sites (16)

Hospital Maternidade São José - UNESC - Fundação Social Rural de Colatina

Colatina, Espírito Santo, Brazil

Location

Hospital da Bahia

Salvador, Estado de Bahia, Brazil

Location

Hospital da Cidade

Salvador, Estado de Bahia, Brazil

Location

Hospital Universitário de Brasília

Brasília, Federal District, Brazil

Location

Hospital Municipal de Maringá

Maringá, Paraná, Brazil

Location

Hospital Regional do Baixo Amazonas Dr. Waldemar Penna

Santarém, Pará, Brazil

Location

Hospital das Clínicas da Universidade Federal de Pernambuco

Recife, Pernambuco, Brazil

Location

Hospital Geral de Caxias do Sul

Caxias do Sul, Rio Grande do Sul, Brazil

Location

Hospital Santa Cruz

Santa Cruz do Sul, Rio Grande do Sul, Brazil

Location

Hospital Nereu Ramos

Florianópolis, Santa Catarina, Brazil

Location

Instituto Baía Sul de Ensino e Pesquisa Irineu May Brodbeck

Florianópolis, Santa Catarina, Brazil

Location

Hospital São Lucas

Aracaju, Sergipe, Brazil

Location

Hospital Aviccena

São Paulo, São Paulo, Brazil

Location

Hospital Naval Marcílio Dias

Rio de Janeiro, Brazil

Location

AC Camargo Câncer Center

São Paulo, Brazil

Location

BP-A Beneficiência Portuguesa de São Paulo

São Paulo, Brazil

Location

MeSH Terms

Conditions

Cross Infection; Pneumonia, Ventilator-Associated

Interventions

Surface-Active Agents; Soaps

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Healthcare-Associated Pneumonia; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specialty Uses of Chemicals; Chemical Actions and Uses; Detergents; Household Products; Technology, Industry, and Agriculture

Study Officials

• Bruno M Tomazini, M.D

  btomazini@hcor.com.br

  PRINCIPAL INVESTIGATOR

• Alexandre B Cavalcanti, M.D

  HCor Research Institute Director

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 2, 2022
• Study Start: August 3, 2022
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: June 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 1 year after publication of primary results
• Access Criteria: Submission of a statistical analysis plan for the purposed analyses. Compliance with Brazilian. Data privacy law.

Locations

BR (16)