NCT07233837

Brief Summary

Healthcare-associated infections (HAIs) remain a major problem in intensive care units (ICUs), driven by environmental contamination with multidrug-resistant organisms that persist despite routine manual cleaning. While hydrogen peroxide aerosolization and ultraviolet-C light devices have shown promise in reducing surface contamination, current evidence is inconsistent, mostly derived from single-center studies, and rarely linked to patient-centered outcomes. The investigators will conduct this cluster-randomized, crossover trial in 12 Brazilian ICUs. Each ICU will sequentially implement three strategies: (1) usual surface disinfection; (2) usual surface disinfection followed by hydrogen peroxide aerosolization at 7.9% concentration, applied through a dedicated device inside a protective tent during terminal cleaning of patient beds; and (3) usual surface disinfection followed by automated ultraviolet-C irradiation, also applied under the same tent to shield adjacent occupied beds. The primary outcome will be the antimicrobial utilization, measured as daily defined doses (DDD) of antimicrobials at the ICU level per 100 patient-days, with secondary outcomes including HAI incidence rate, environmental contamination with multidrug-resistant organisms, specific HAIs incidence rate (associated-ventilator pneumonia, central-line associated bloodstream infection, and catheter-associated urinary tract infection), and ICU length of stay costs.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for not_applicable

Timeline
10mo left

Started Jan 2026

Geographic Reach
1 country

12 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress29%
Jan 2026Mar 2027

First Submitted

Initial submission to the registry

November 14, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

January 5, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2027

Expected
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

April 15, 2026

Status Verified

January 1, 2026

Enrollment Period

1.1 years

First QC Date

November 14, 2025

Last Update Submit

April 10, 2026

Conditions

Keywords

Healthcare associated infectionsAntimicrobial useIntensive care unitspneumonia, ventilator-associatedCatheter-related infectionsUrinary tract infectionsHydrogen PeroxideUltraviolet light

Outcome Measures

Primary Outcomes (1)

  • Antimicrobial utilization at the ICU level

    Antimicrobial utilization, measured as daily defined doses (DDD) of antimicrobials at the ICU level per 100 patient-days

    3 months

Secondary Outcomes (6)

  • Healthcare-associated infections

    3 months

  • Contamination of environmental surfaces by multi-resistant microorganisms

    3 months

  • Incidence density of ventilator-associated pneumonia

    3 months

  • Incidence density of central line-associated bloodstream infections

    3 months

  • Incidence density of catheter-associated urinary tract infection

    3 months

  • +1 more secondary outcomes

Study Arms (3)

Surface disinfection with aerosolized hydrogen peroxide

EXPERIMENTAL

The hygiene team of each participating ICU will spray aerosolized peroxide hydrogen using a specific device when performing terminal cleaning of the ICU bed after the patient's discharge. As peroxide hydrogen aerosol can be irritating to people nearby, we will use a tent designed to cover the bed and nearby equipment during peroxide hydrogen disinfection, thus preventing aerosols from spreading to other beds and other areas of ICUs where beds are not in closed rooms.

Other: Aerosol of hydrogen peroxide

Surface disinfection with irradiation of ultraviolet light

EXPERIMENTAL

The hygiene team of each participating ICU will use a specific device, requiring no manipulation, for irradiating UV light for the purpose of disinfecting beds and surfaces near beds during terminal cleaning. To prevent UV irradiation from reaching occupied beds and other areas of the ICU, the same tent described in the "peroxide hydrogen" arm.

Other: Irradiation of ultraviolet light

Usual disinfection

NO INTERVENTION

The control group will perform standard cleaning and disinfection of the beds and the environment according to their previous protocols, using the usual products.

Interventions

Spray of aerosolized peroxide hydrogen using a specific device when performing terminal cleaning of the ICU bed after the patient's discharge.

Also known as: Hydrogen Peroxide
Surface disinfection with aerosolized hydrogen peroxide

Irradiation of UV light for the purpose of disinfecting beds and surfaces near beds during terminal cleaning.

Also known as: Ultraviolet light
Surface disinfection with irradiation of ultraviolet light

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients aged 18 years and older who will be admitted to the participating ICUs

You may not qualify if:

  • Patients under 18 years
  • ICUs that use peroxide hydrogen or ultraviolet light for surface disinfection as part of their protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Hospital Maternidade Sao Vicente De Paulo

Barbalha, Ceará, Brazil

RECRUITING

Instituto Hospital de Base

Brasília, Federal District, Brazil

RECRUITING

Hospital Estadual de Aparecida de Goiânia

Aparecida de Goiânia, Goiás, Brazil

RECRUITING

Santa Casa de Misericórdia de Passos

Passos, Minas Gerais, Brazil

RECRUITING

Fundo Municipal de Saúde de Maringá

Maringá, Paraná, Brazil

RECRUITING

Hospital da Restauração

Recife, Pernambuco, Brazil

RECRUITING

Hospital Universitário da Universidade Federal do Piauí

Teresina, Piauí, Brazil

RECRUITING

Hospital Universitário Onofre Lopes

Natal, Rio Grande do Norte, Brazil

RECRUITING

Hospital Geral de Caxias do Sul

Caxias do Sul, Rio Grande do Sul, Brazil

RECRUITING

Hospital de Pronto Socorro de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

RECRUITING

Hospital Dr Leo Orsi Bernardes

Itapetininga, São Paulo, Brazil

RECRUITING

Hospital Pelópidas Silveira

Recife, Brazil

RECRUITING

MeSH Terms

Conditions

Cross InfectionUrinary Tract InfectionsPneumonia, Ventilator-AssociatedCatheter-Related Infections

Interventions

Hydrogen PeroxideUltraviolet Rays

Condition Hierarchy (Ancestors)

InfectionsIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesHealthcare-Associated PneumoniaPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PeroxidesOxidesAnionsIonsElectrolytesInorganic ChemicalsReactive Oxygen SpeciesFree RadicalsOxygen CompoundsOrganic ChemicalsLightElectromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaOptical PhenomenaRadiationRadiation, IonizingRadiation, NonionizingSunlightWeatherAtmosphereEnvironmentEcological and Environmental PhenomenaBiological PhenomenaMeteorological ConceptsEnvironment and Public Health

Study Officials

  • Antonio P Nassar Jr, PhD

    Hospital Israelita Albert Einstein

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio P Nassar Jr, PhD

CONTACT

Adriano J Pereira, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Randomized, controlled, cluster, crossover, trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2025

First Posted

November 18, 2025

Study Start

January 5, 2026

Primary Completion (Estimated)

February 26, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

April 15, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

The sharing of individual participant data is subject to approval by the Institutional Review Boards and the Brazilian Ministry of Health.

Locations