Daily Chlorexidine Bath for Health Care Associated Infection Prevention

Ventilator Associated Pneumonia Clinical Trial

— CLEAN-IT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05485051
• Other study ID #: ip_hcor_cleanit
• Status: Completed
• Phase: Phase 3
• Start date: August 3, 2022
• Est. completion date: March 31, 2024

Study information

• Verified date: May 2024
• Source: Hospital do Coracao
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15730
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• History of chlorhexidine allergy

Related Conditions & MeSH terms

• Catheter-Associated Urinary Tract Infection
• Central Line-associated Bloodstream Infection (CLABSI)
• Communicable Diseases
• Cross Infection
• Health Care Associated Infection
• Infections
• Pneumonia, Ventilator-Associated
• Sepsis
• Urinary Tract Infections
• Ventilator Associated Pneumonia

Intervention

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.
• 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.

Locations

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

Sponsors (6)

Lead Sponsor	Collaborator
Hospital do Coracao	A Beneficência Portuguesa de São Paulo, Hospital Alemão Oswaldo Cruz, Hospital Israelita Albert Einstein, Hospital Moinhos de Vento, Hospital Sírio-Libanês

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Ventilator associated pneumonia (VAP)	Rates of Ventilator associated pneumonia (VAP)	Within each cluster duration (90 days)
Secondary	Central line-associated blood stream infections (CLABSI)	Rates of Central line-associated blood stream infections (CLABSI)	Within each cluster duration (90 days)
Secondary	Catheter-associated urinary tract infection (CAUTI)	Rates of Catheter-associated urinary tract infection (CAUTI)	Within each cluster duration (90 days)
Secondary	Hospital length of stay	Hospital length of stay	Until hospital discharge, maximum 90 days
Secondary	Intensive Care Unit length of stay	Intensive Care Unit length of stay	Until Intensive Care Unit discharge, maximum 90 days
Secondary	Antibiotic use	Antibiotic use per unit	Within each cluster duration (90 days)
Secondary	In hospital mortality	In hospital mortality	Maximum 90 days after randomization
Secondary	Intensive Care Unit mortality	Intensive Care Unit mortality	Maximum 90 days after randomization