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

NCT07684300 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-07-06

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Maria Espinosa Perez

    lead OTHER

Principal Investigators

  • Mar Masiá Canuto, MD, PhD · Hospital General Universitario de Elche / Universidad Miguel Hernández

  • Félix Gutiérrez Rodero, MD, PhD · Hospital General Universitario de Elche / Universidad Miguel Hernández

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-10
Primary Completion
2027-04-30
Completion
2027-06-30

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07684300 on ClinicalTrials.gov