RecruitingNot ApplicableNCT07684300

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

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


Sponsor

Maria Espinosa Perez

Enrollment

250 participants

Start Date

Apr 10, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria4

  • 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.

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Interventions

BEHAVIORALProtocolized Antimicrobial Stewardship Strategy

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

BEHAVIORALStandard 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

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NCT07684300


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