Rapid, multiplex microbiology–guided antibiotic stewardship in hospitalized adults
Official title: Impact of Molecular Microbiology Integrated With Clinical Data on Antimicrobial Therapy Optimization: An Open-Label Cluster-Randomized Crossover Trial
Run by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana · NCT07684300 · Data updated 2026-11-12
This study tests whether using fast multiplex molecular results plus predefined criteria within an antimicrobial stewardship program can shorten high-impact antibiotic use and improve treatment decisions in hospitalized adults.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 250 (estimated) |
| Sponsor | Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana Academic / other |
| Locations | 1 site (Elche, Alicante) |
| Status | Recruiting |
| Started | April 10, 2026 |
| Main results expected | April 2027 |
| Study ends | June 2027 |
| Registry record updated | July 6, 2026 |
| Trial ID | NCT07684300 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) hospitalized and starting empiric high‑impact antibiotics, able to consent, and treated within participating units.
✕Probably not a fit
Patients not receiving rapid diagnostic–guided decisions or those with conditions unlikely to be affected by stewardship changes may see no benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study compares a protocolized antimicrobial stewardship approach that incorporates rapid multiplex molecular microbiology results with standard stewardship. It enrolls adults hospitalized on high‑impact empiric therapy and randomizes them to receive the protocolized strategy or usual care. Outcomes include duration of high‑impact antibiotic exposure, appropriateness of therapy, and clinical outcomes such as readmission, ICU care, infection recurrence, mortality, and costs. The study aims to identify how best to integrate rapid diagnostic results into real‑world stewardship decisions to optimize antimicrobial use. Recruitment occurs at Hospital General Universitario de Elche in Spain, with adult participants who consent.
Why it matters
Potential benefit: If successful, patients may experience shorter exposure to broad-spectrum antibiotics and more appropriate therapy, potentially reducing adverse effects and costs.
How similar studies have gone: Previous work shows rapid diagnostics can improve diagnosis, but clear benefits require integration into structured decision‑making; this study tests that integration.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years * Hospitalized in one of the participating study units at Hospital General Universitario de Elche. * Initiation of empiric high-impact antimicrobial therapy subject to antimicrobial stewardship program (ASP) review. * Provision of written informed consent by the participant or, when applicable, by a legally authorized representative. Exclusion Criteria: * Severe immunosuppression with profound neutropenia (\<100 neutrophils/mm³). * Previous enrollment in this clinical trial. * Expected survival of less than 48 hours. * Documented microbiological identification of the presumed causative pathogen by conventional methods in a representative and/or sterile sample before randomization and before availability of multiplex molecular microbiology results.
Where it's running
-
Hospital General Universitario de Elche
Elche, Alicante, Spain Recruiting
Study contacts
- Study coordinator: María Espinosa Pérez, MD
- Email: espinosa_mariaper@gva.es
- Phone: +34 675047622
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.