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RECRUITING
NCT07684300
NA

Molecular Microbiology- Guided Antimicrobial Stewardship Versus Standard Stewardship in Hospitalized Patients

Sponsor: Maria Espinosa Perez

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn whether integrating rapid multiplex molecular microbiology results with predefined clinical and laboratory criteria into an antimicrobial stewardship program improves antimicrobial use in hospitalized adults receiving empiric high-impact antimicrobial therapy. The main questions it aims to answer are: Does this strategy reduce the duration of exposure to high-impact antimicrobial therapy compared with standard antimicrobial stewardship practice? Does this strategy improve the appropriateness of antimicrobial treatment? Does this strategy affect clinical outcomes, including hospital readmission, intensive care unit admission, infection recurrence, mortality, and healthcare costs? Researchers will compare a protocolized antimicrobial stewardship strategy that incorporates multiplex molecular microbiology results and predefined clinical criteria with the standard antimicrobial stewardship strategy currently used in the hospital. Participants will: Receive antimicrobial management according to the stewardship strategy assigned to their hospital unit during the study period. Undergo molecular microbiology testing and routine clinical and laboratory assessments as part of standard hospital care when indicated. Be followed to evaluate antimicrobial exposure, treatment appropriateness, safety outcomes, hospital readmission, intensive care unit admission, infection recurrence, mortality, and healthcare costs.

Official title: Impact of Molecular Microbiology Integrated With Clinical Data on Antimicrobial Therapy Optimization: An Open-Label Cluster-Randomized Crossover Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2026-04-10

Completion Date

2027-06

Last Updated

2026-07-06

Healthy Volunteers

No

Interventions

BEHAVIORAL

Protocolized Antimicrobial Stewardship Strategy

A standardized antimicrobial stewardship strategy integrating multiplex molecular microbiology results with predefined clinical and laboratory criteria to support antimicrobial prescribing decisions.

BEHAVIORAL

Standard Antimicrobial Stewardship

Routine antimicrobial stewardship practice based on standard clinical assessment and conventional microbiological information.

Locations (1)

Hospital General Universitario de Elche

Elche, Alicante, Spain