Antimicrobial, Catheter Related Blood Stream Infections, Infection, Hospital, Pneumonia Associated With Mechanical Ventilation, Urinary Tract Infection(UTI)
Conditions
Keywords
Healthcare associated infections, Antimicrobial use, Intensive care units, pneumonia, ventilator-associated, Catheter-related infections, Urinary tract infections, Hydrogen Peroxide, Ultraviolet light
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.
Interventions
OTHERAerosol of hydrogen peroxide
Spray of aerosolized peroxide hydrogen using a specific device when performing terminal cleaning of the ICU bed after the patient's discharge.
OTHERIrradiation of ultraviolet light
Irradiation of UV light for the purpose of disinfecting beds and surfaces near beds during terminal cleaning.
Sponsors
Hospital Israelita Albert Einstein
Hospital Sirio-Libanes
Hospital do Coracao
Beneficência Portuguesa de São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Randomized, controlled, cluster, crossover, trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients aged 18 years and older who will be admitted to the participating ICUs
Exclusion criteria
* Patients under 18 years * ICUs that use peroxide hydrogen or ultraviolet light for surface disinfection as part of their protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antimicrobial utilization at the ICU level | 3 months | Antimicrobial utilization, measured as daily defined doses (DDD) of antimicrobials at the ICU level per 100 patient-days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Healthcare-associated infections | 3 months | Incidence rate of device healthcare-associated infections during ICU admission |
| Contamination of environmental surfaces by multi-resistant microorganisms | 3 months | 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. |
| 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 | — |
| Intensive care unit length of stay costs | 3 months | — |
Countries
Brazil
Contacts
CONTACTAntonio P Nassar Jr, PhD
CONTACTAdriano J Pereira, PhD
PRINCIPAL_INVESTIGATORAntonio P Nassar Jr, PhD
Hospital Israelita Albert Einstein
Outcome results
None listed