Application of an Antimicrobial Stewardship Program in Brazilian ICUs Using Machine Learning Techniques and an Educational Model

NCT05312034 | Unknown

• 1 other identifier: 15054519.3.0000.5249C
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Antimicrobial agents are frequently used empirically and include therapy for both Gram-positive and Gram-negative bacteria. In Brazil, multidrug-resistant Gram-negative pathogens are the cause of most nosocomial infections in ICUs. Therefore, the excessive use of antimicrobials to treat Gram-positive bacteria represents an opportunity to reduce unnecessary antibiotic use in critically ill patients. Besides, the success of a program aimed at reducing the use of antibiotics to treat gram-positive bacteria could also evolve to include other microorganisms, such as gram-negative bacteria and fungi. Analyzing data from the ICUs of the associated hospital network, high use of broad-spectrum antibiotics and vancomycin were observed, although MRSA infections rarely occur. Thus, if physicians could identify patients at high risk of infection by gram-positive bacteriaa reduction in antibiotic consumption could occur.. The more accurate treatments could result in better patient outcomes, reduce the antibiotics' adverse effects, and decrease the prevalence of multidrug-resistant bacteria. Therefore, our main goal is to reduce antibiotic use by applying an intervention with three main objectives: (i) to educate the medical team, (ii) to provide a tool that can help physicians prescribing antibiotics, and (iii) to find and reduce differences in antibiotic prescription between hospitals with low- and high-resources. To achieve these objectives, he same intervention will be applied in ICUs of two hospitals with different access to resources. Both are part of a network of hospitals associated with our group. First, baseline data corresponding to patient characteristics, antibiotic use, microbiological outcomes and current administration programs in practice at selected hospitals will be analyzed. TThen, a predictive model to detect patients at high risk of Gram-positive infection will be developed. After that, t will be applied for three months as an educational tool to improve medical decisions regarding antibiotic prescription. After obtaining feedback and suggestions from physicians and other hospital and infection control members, the model will be adjusted and applied in the two selected hospitals for use in real time. For one year, we will monitor the intervention and analyze the data monthly.

Conditions

Nosocomial Infection; Sepsis

Keywords

antimicrobial; antibiotics

Outcome Measures

Primary Outcomes (2)

• Antimicrobial consumption

  It was evaluated through the Defined Daily Dose (DDD): The assumed average maintenance dose per day for a drug used for its main indication in adults; and Duration of Treatment (DOT):Duration of Treatment with antibiotics.

  Baseline

• Antimicrobial consumption

  It was evaluated through the Defined Daily Dose (DDD): The assumed average maintenance dose per day for a drug used for its main indication in adults; and Duration of Treatment (DOT): Duration of Treatment with antibiotics

  During the intervention

Secondary Outcomes (2)

• Mortality

  number of deaths in 60 days

• Gram-positive infection

  immediately after the microbiologics analysis

Study Arms (1)

Application of an antimicrobial stewardship program in ICUs

EXPERIMENTAL

Application of an antimicrobial stewardship program in Brazilian ICUs using machine learning techniques and an educational model

Behavioral: Implementation of the predictive model for an antimicrobial management program

Interventions

Implementation of the predictive model for an antimicrobial management program BEHAVIORAL

Firstly it will be used the predictive model as a simulation tool to educate physicians. For three months, physicians will use the model to understand the main factors associated with Gram-positive infection. They will test the model using real-case data previously collected at the hospitals. The model will provide them information such as the probability of that patient having a Gram-positive infection and the proportion of infected patients in that ICU and hospital. This model will be embedded in an app and a web page to provide real-time guidance on the predicted probability of infection due to Gram-positive agents. The intervention will be implemented in two selected hospitals, aiming at monthly decreasing the use of broad-spectrum antibiotics while maintaining or reducing the ICU standardized mortality ratio and the standardized resource use.

Application of an antimicrobial stewardship program in ICUs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• prescribers from the hospital units participating in the study.

You may not qualify if:

• prescribers who do not work in intensive care units.
• refusal to participate

Sponsors & Collaborators

• D'Or Institute for Research and Education: lead

MeSH Terms

Conditions

Cross Infection; Sepsis

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Systemic Inflammatory Response Syndrome; Inflammation

Study Officials

• Fernando Bozza, PhD

  D'Or Institute for Research and Education (IDOR)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernando Bozza, PhD

CONTACT

55 21 993031551; bozza.fernando@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A predictive model to identify patients at risk of Gram-positive infection. This model will be embedded in an app and a web page to provide real-time guidance on the predicted probability of infection due to Gram-positive agents. The intervention will be implemented in two selected hospitals, aiming at monthly decreasing the use of broad-spectrum antibiotics while maintaining or reducing the ICU standardized mortality ratio and the standardized resource use.

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: April 5, 2022
• Study Start: April 1, 2022
• Primary Completion: December 29, 2023
• Study Completion: December 29, 2023
• Last Updated: April 5, 2022

Record last verified: 2022-03