Evaluation of the Artificial Intelligence-based Prescription Support Software iAST® for the Choice of Empirical and Semi-targeted Antibiotic Treatment
Trial ID: NCT06174519
Status: COMPLETED
Study type: OBSERVATIONAL
Start date: 2023-08-01
Completion date: 2023-12-01
Sponsor: Pragmatech AI Solutions
Collaborators: NAMSA; Grupo Hospital de Madrid
Conditions: Bacterial Infections
Interventions: Medical device simulation
Locations: Grupo HM Hospitales
Countries: Spain
Enrollment: 325
Age range: 18 Years - None
Sex: ALL

Summary:
Inadequate treatment of infections frequently leads to complications that cause new visits to the doctor, lengthen hospital stays and can lead to sepsis, even causing the death of affected patients. Several scientific studies have documented that up to 20%-30% of antibiotic prescriptions are incorrect and do not cover the microorganism causing the infection. iAST® is a simple antibiotic prescribing aid tool that applies complex algorithms based on the latest artificial intelligence technologies to accurately predict the best specific antibiotic for a patient, before knowing the definitive microbiological results (bacterial identification and antibiogram). The objective of the present trial is to demonstrate the non-inferiority of iAST® with respect to physicians for the appropriate choice of empiric and semi-directed therapy of common infectious diseases, including sepsis, urinary tract infections and ventilator-associated pneumonias or tracheobronchitis. The adequacy of the medical prescription and the iAST® prediction will be compared taking the antibiogram report as a reference. The study design is retrospective, so that no intervention will be done on the patients. The investigators will conduct a retrospective search for infection cases and note the antibiotic treatment prescribed by the doctors. In parallel, they will enter basic patient data such as age, sex, service where they were treated, type of infection and microorganism (in the case of semi-directed treatment evaluation) into the iAST® software and will write down the first three treatment options recommended by the tool. The treatments of both arms (medical treatment and iAST® prediction) will be compared with the microbiological results and the success rate of each of them will be calculated.

Eligibility criteria:
Inclusion Criteria:

1. Data for analysis should proceed from subjects over 18 years old that were admitted into HM Hospitals from 01Feb2023.
2. Subjects who:

   * have attended the Emergency Department of the hospital with suspected urinary tract infection (UTI) or;
   * have presented an episode of bacteremia/sepsis at/during hospital admission or;
   * have been admitted to the hospital ICU and presented a tracheobronchitis or pneumonia associated with mechanical ventilation or;
   * have presented another type of infection, were treated and which have a bacterium identified with an antibiogram result.

Exclusion Criteria:

1. Patients with concomitant infections.
2. Data from subjects suffered from infections with no bacterial etiology: fungal or viral infections.
3. Data from subjects with infections without microbiological documentation (including antibiogram results).
4. Data from subjects prescribed with more than one antibiotic.

Outcomes:
To demonstrate the non-inferiority of iAST® compared to physicians for the prescription of the empiric and semitargeted antibiotic therapy in patients with common infectious diseases.