ClinicalTrials.gg
Not yet recruitingNCT07762378Updated Aug 13, 2026

Clinical Impact of a Machine Learning Decision Support System for Empirical Antibiotic Therapy

An interventional study of Machine Learning Decision Support System in Pneumonia - Bacterial, Urinary Tract Infection Bacterial and Bloodstream Infection, sponsored by Instituto de Investigación Sanitaria Gregorio Marañón. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by Instituto de Investigación Sanitaria Gregorio Marañón · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
486
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this quasi-experimental study is to analyze if a Machine Learning Clinical Decision Support System can improve the empirical antibiotic treatment in patients with pneumonia, urinary tract infection and / or sepsis.

The main questions it aims to answer are:

  • Primary outcome: clinical success defined as clinical cure (resolution of all signs and symptoms related to infection); no complications until day 30 (recurrence, or development of adverse events- AEs-); no new acquisition of MDROs; and survival at day 30.
  • Secondary outcomes: a subgroup analysis of the primary outcome according to the department participants, infectious syndrome, severity of the infection assessed by the SOFA score, and in microbiological confirmed infections. In microbiological confirmed infections, desirability of Outcome Ranking (DOOR) for the Management of Antimicrobial Therapy (MAT) according to the beta-lactam classification

Researchers will compare a pre-intervention group with a post-intervention to see if improve in the DOOR MAT score

Participants in the post-intervention group will:

  • Received empirical antibiotic therapy prescribed by their treating physicians according to the machine-learning recommendations
02

Conditions studied

  • Pneumonia - Bacterial
  • Urinary Tract Infection Bacterial
  • Bloodstream Infection

Keywords

  • antibiotics
  • empiric therapy
  • clinical decision support system
  • multidrug resistant microorganism
  • antimicrobial stewardship
03

In context

Pneumonia, Bacterial

153 studies on the registry are indexed under Pneumonia, Bacterial; 27 are open to participants now.

This study's planned enrollment of 486 is above the median of 132 across 107 interventional studies indexed under Pneumonia, Bacterial.

Browse Pneumonia, Bacterial studies →

Lead sponsor

Instituto de Investigación Sanitaria Gregorio Marañón is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult patients (aged ≥18 years)
  • Admitted to the Nephrology, Oncology or ICU wards
  • Diagnosis of sepsis, pneumonia and/or UTI
  • Empirical antibiotics prescribed

Exclusion criteria

Exclusion Criteria:

  • obtained > 48 hours since the infection onset
  • beta-lactam allergy
  • infection syndrome other than sepsis, pneumonia or UTI
  • confirmed no-bacterial infection
  • death within the first 48 hours of inclusion or imminent risk of death at time of the inclusion
  • pregnancy and/or breastfeeding
  • inclusion in a clinical trial of antimicrobial treatment
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
486 participants (estimated)

Study arms

  • No intervention
    Pre-interventional

    Hospital standard practices for diagnosis and/or treatment applied

  • Experimental
    Interventional

    Hospital standard practices + use of a CDSS tool

    Other: Machine Learning Decision Support System

Interventions

  • OtherMachine Learning Decision Support System

    iAST® (Pragmatech AI Solutions) is a medical device designed to assist the antibiotic prescription, currently approved by the European Medicines Agency. It used complex algorithms to accurately predict the most likely recommended antibiotics for providing coverage for specific aerobic bacteria before definitive microbiological results, bacterial identification and antibiotic susceptibility testing, were known

06

What researchers measure

Primary outcomes

  1. Clinical success

    resolution of all signs and symptoms related to infection with no complications and survival

    Time frame: 30-Day

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Aug 2027, 11 months later.

Of 19 interventional studies with no phase under Pneumonia, Bacterial, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 39. This study's planned 11 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 5, 2026
First posted
Aug 13, 2026
StartEst.
Sep 2026
Primary completionEst.
Aug 2027
CompletionEst.
Sep 2027
Last update
Aug 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07762378
Lead sponsor
Instituto de Investigación Sanitaria Gregorio Marañón
Responsible party
Sofia De La Villa (Principal Investigator, Instituto de Investigación Sanitaria Gregorio Marañón) — Principal investigator
First posted
Aug 13, 2026
Start date
Sep 2026 (estimated)
Primary completion
Aug 2027 (estimated)
Completion
Sep 2027 (estimated)
Last update
Aug 13, 2026

Study contacts

Sofía De la Villa
Contact
sofiadela.villa@salud.madrid.org
34912868453

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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