Molecular Microbiology- Guided Antimicrobial Stewardship Versus Standard Stewardship in Hospitalized Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMaria Espinosa Perez
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
Protocolized Antimicrobial Stewardship Strategy
BehavioralA standardized antimicrobial stewardship strategy integrating multiplex molecular microbiology results with predefined clinical and laboratory criteria to support antimicrobial prescribing decisions.
Standard Antimicrobial Stewardship
BehavioralRoutine antimicrobial stewardship practice based on standard clinical assessment and conventional microbiological information.
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: Molecular Microbiology-Guided StewardshipExperimental treatment 1 intervention
Group B: Standard Antimicrobial StewardshipActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Duration of Exposure to High-Impact Antimicrobial Therapy
Total number of days of exposure to high-impact antimicrobial therapy from randomization until hospital discharge under antimicrobial stewardship program supervision.
Time frame
Up to 30 days after initiation of high-impact antimicrobial therapySecondary outcomes
1
Infection-Related Mortality
Mortality within 30 days in which infection is considered the cause or a contributing factor.
Time frame
30 days2
Antimicrobial-Related Adverse Events
Occurrence of antimicrobial-related adverse events, including Clostridioides difficile infection, allergic reactions, acute kidney injury, hepatotoxicity, and clinically significant drug interactions.
Time frame
Up to 30 days after randomization3
Appropriate Antimicrobial Therapy at 24 Hours
Proportion of patients receiving appropriate antimicrobial therapy, defined as active therapy against the identified pathogen and the narrowest effective antimicrobial spectrum.
Time frame
24 hours after randomization4
Appropriate Antimicrobial Therapy at 72 Hours
Proportion of patients receiving appropriate antimicrobial therapy, defined as active therapy against the identified pathogen and the narrowest effective antimicrobial spectrum.
Time frame
72 hours after randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Maria Espinosa Perez
Lead sponsor
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Sponsor institution
Source ClinicalTrials.gov