Infection, HospitalHylightNCT07233837
Hydrogen Peroxide and Ultraviolet Light for Disinfecting Surfaces in Intensive Care Units
A study testing Aerosol of hydrogen peroxide and Irradiation of ultraviolet light in people with Infection, Hospital and Antimicrobial, run by Hospital Israelita Albert Einstein at 12 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection, Hospital, Antimicrobial, Pneumonia Associated With Mechanical Ventilation
- What is being tested?
- Aerosol of hydrogen peroxide and Irradiation of ultraviolet light
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 12 sitesBrazil
- Study dates
- 5 Jan 2026to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients aged 18 years and older who will be admitted to the participating ICUs
Who cannot join
- Patients under 18 years
- ICUs that use peroxide hydrogen or ultraviolet light for surface disinfection as part of their protocol
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
Brazil12 sites, 12 recruiting
- Recruiting
Hospital Estadual de Aparecida de Goiânia
Aparecida de Goiânia, Goiás
Wallef S Rodrigues, 55-62-3983-1750
- Recruiting
Hospital Maternidade Sao Vicente De Paulo
Barbalha, Ceará
Meton S Alencar Filho, 55-85-3532-7100, meton.filho@icloud.com
- Recruiting
Instituto Hospital de Base
Brasília, Federal District
Glecia C Rocha, 55-61-3550-8900, gleciacarla@yahoo.com.br
- Recruiting
Hospital Geral de Caxias do Sul
Caxias do Sul, Rio Grande do Sul
Emerson B da Silva, 55543128700, boschimd@gmail.com
- Recruiting
Hospital Dr Leo Orsi Bernardes
Itapetininga, São Paulo
Vivian M Irineu, 55-15-3275-7800, virineu@gmail.com
- Recruiting
Fundo Municipal de Saúde de Maringá
Maringá, Paraná
Francielle C Pereira, 55-44-3127-3100
- Recruiting
Hospital Universitário Onofre Lopes
Natal, Rio Grande do Norte
Eliane P da Silva, 55-84-3342-5000, eliane.psilva@esberh.gov.br
- Recruiting
Santa Casa de Misericórdia de Passos
Passos, Minas Gerais
Priscila F Gonçalves, 88-35-3529-1300, ccih.coordenacao@scpassos.org.br
- Recruiting
Hospital de Pronto Socorro de Porto Alegre
Porto Alegre, Rio Grande do Sul
Marcelle R Schettert, 55-51-3289-7999, marcelle.schettert@portoalegre.rs.gov.br
- Recruiting
Hospital da Restauração
Recife, Pernambuco
Debora M Pinho, 55-81-3181-5400, debypinho61@gmail.com
- Recruiting
Hospital Pelópidas Silveira
Recife
Livia A de Medeiros, 55-81-3183-0388, liviamedeiros@hotmail.com
- Recruiting
Hospital Universitário da Universidade Federal do Piauí
Teresina, Piauí
Rejane M Prestes, 55-86-3228-5201, prestesrejane@gmail.com
About this study
Official title: Hydrogen Peroxide and Ultraviolet Light for Disinfecting Surfaces in Intensive Care Units: A Randomized, Controlled, Cluster, Crossover Clinical Trial
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.
- Conditions
- Infection, Hospital, Antimicrobial, Pneumonia Associated With Mechanical Ventilation, Urinary Tract Infection(UTI), Catheter Related Blood Stream Infections
- Being tested
- Aerosol of hydrogen peroxide, Irradiation of ultraviolet light
- Keywords
- Healthcare associated infections, Antimicrobial use, Intensive care units, pneumonia, ventilator-associated, Catheter-related infections, Urinary tract infections, Hydrogen Peroxide, Ultraviolet light
- Medical subject headings
- Cross Infection, Urinary Tract Infections, Pneumonia, Ventilator-Associated, Catheter-Related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerosol of hydrogen peroxideOther
Also called Hydrogen Peroxide
Spray of aerosolized peroxide hydrogen using a specific device when performing terminal cleaning of the ICU bed after the patient's discharge.
Irradiation of ultraviolet lightOther
Also called Ultraviolet light
Irradiation of UV light for the purpose of disinfecting beds and surfaces near beds during terminal cleaning.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antimicrobial utilization at the ICU level
Antimicrobial utilization, measured as daily defined doses (DDD) of antimicrobials at the ICU level per 100 patient-days
Measured: 3 months
Secondary outcomes (6)
Healthcare-associated infections
Incidence rate of device healthcare-associated infections during ICU admission
Measured: 3 months
Contamination of environmental surfaces by multi-resistant microorganisms
We will collect environmental samples from 4 surfaces highly touched by the patient, health team and family (bed rails, monitor and infusion pump buttons, meal table or procedure table, and IV drip stand) before and after the intervention. For analysis of the environmental samples, characterization of the density and microbiological profile of biofilms on the different surfaces of the ICU beds will be performed using large-scale DNA sequencing techniques associated with bioinformatics analysis.
Measured: 3 months
Incidence density of ventilator-associated pneumonia
Measured: 3 months
Incidence density of central line-associated bloodstream infections
Measured: 3 months
Incidence density of catheter-associated urinary tract infection
Measured: 3 months
Intensive care unit length of stay costs
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start5 Jan 2026
- Primary completion26 Feb 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, HospitalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, controlled, cluster, crossover, trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Sirio-Libanes, Hospital do Coracao, Beneficência Portuguesa de São Paulo
- Responsible party
- Sponsor
- Investigators
- Antonio P Nassar Jr, PhD, Principal investigator, Hospital Israelita Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07233837
- Sponsor's protocol ID
- CAAE 71265723.0.1001.0071
- Acronym
- Hylight
- Status last verified
- Jan 2026
- First submitted
- 14 Nov 2025
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The sharing of individual participant data is subject to approval by the Institutional Review Boards and the Brazilian Ministry of Health.
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydrogen Peroxide and Ultraviolet Light for Disinfecting Surfaces in Intensive Care Units: A Randomized, Controlled, Cluster, Crossover Clinical Trial
- ClinicalTrials.gov ID
- NCT07233837
- Acronym / sponsor ID
- Hylight / CAAE 71265723.0.1001.0071
- Conditions
- Infection, Hospital, Antimicrobial, Pneumonia Associated With Mechanical Ventilation, Urinary Tract Infection(UTI), Catheter Related Blood Stream Infections
- Keywords
- Healthcare associated infections, Antimicrobial use, Intensive care units, pneumonia, ventilator-associated, Catheter-related infections, Urinary tract infections, Hydrogen Peroxide, Ultraviolet light
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Collaborators
- Hospital Sirio-Libanes, Hospital do Coracao, Beneficência Portuguesa de São Paulo
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 26 Feb 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized, controlled, cluster, crossover, trial
| Arm | Type | Receives |
|---|---|---|
| Surface disinfection with aerosolized hydrogen peroxide | Experimental | Other: Aerosol of hydrogen peroxideThe 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. |
| Surface disinfection with irradiation of ultraviolet light | Experimental | Other: Irradiation of ultraviolet lightThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients aged 18 years and older who will be admitted to the participating ICUs
Key exclusion criteria (2 listed)
- Patients under 18 years
- ICUs that use peroxide hydrogen or ultraviolet light for surface disinfection as part of their protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerosol of hydrogen peroxideAlso: Hydrogen PeroxideSpray of aerosolized peroxide hydrogen using a specific device when performing terminal cleaning of the ICU bed after the patient's discharge. | Other | Surface disinfection with aerosolized hydrogen peroxide |
| Irradiation of ultraviolet lightAlso: Ultraviolet lightIrradiation of UV light for the purpose of disinfecting beds and surfaces near beds during terminal cleaning. | Other | Surface disinfection with irradiation of ultraviolet light |
Primary outcome
Antimicrobial utilization at the ICU level
Time frame: 3 months
Antimicrobial utilization, measured as daily defined doses (DDD) of antimicrobials at the ICU level per 100 patient-days
6 secondary outcomes
Healthcare-associated infections
Time frame: 3 months
Contamination of environmental surfaces by multi-resistant microorganisms
Time frame: 3 months
Incidence density of ventilator-associated pneumonia
Time frame: 3 months
Incidence density of central line-associated bloodstream infections
Time frame: 3 months
Incidence density of catheter-associated urinary tract infection
Time frame: 3 months
Intensive care unit length of stay costs
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: No. The sharing of individual participant data is subject to approval by the Institutional Review Boards and the Brazilian Ministry of Health.
Related trials for Infection, Hospital
Not yet recruiting
HAIQU (Hospital AIr QUality)
Acute Respiratory Tract Infection
Not yet recruitingObservational study
Traditional Chinese Medicine in Multidrug-Resistant Bacterial Pneumonia
Multi Drug Resistant Infections, Pneumnia
RecruitingObservational study
POS-ARI-ER Observational Study of Acute Respiratory Infections
Acute Respiratory Infection, Acute Respiratory Tract Infection
Recruiting
Polypharmacy on Healthy Aging in People Living With HIV Over the Age of 75
Virus-HIV
Recruiting
RSV Burden in Outpatient and Hospital Settings
RSV Infection, Children, Only
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Antonio P Nassar Jr, PhD principal investigator
Hospital Israelita Albert Einstein
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerosol of hydrogen peroxide and Irradiation of ultraviolet light in people with Infection, Hospital and Antimicrobial, run by Hospital Israelita Albert Einstein at 12 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonio P Nassar Jr, PhD (551121519617, antonio.nassar@einstein.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antimicrobial utilization at the ICU level (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.