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

Sponsor

Hospital do Coracao (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05485051

Collaborator

Hospital Sírio-Libanês (Other), Hospital Israelita Albert Einstein (Other), Hospital Moinhos de Vento (Other), Hospital Alemão Oswaldo Cruz (Other), A Beneficência Portuguesa de São Paulo (Other)

30,000

Enrollment

Locations

Arms

16.7

Anticipated Duration (Months)

1875

Patients Per Site

112.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Health Care Associated Infection Ventilator Associated Pneumonia Central Line-associated Bloodstream Infection (CLABSI) Catheter-Associated Urinary Tract Infection	Other: 2% chlorhexidine digluconate solution with surface-active agents Other: Usual Baths	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30000 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention 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.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:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Aug 10, 2022

Anticipated Primary Completion Date :

Dec 10, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

History of chlorhexidine allergy

Contacts and Locations

Locations

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