NCT07684300 Molecular Microbiology- Guided Antimicrobial Stewardship Versus Standard Stewardship in Hospitalized Patients
| NCT ID | NCT07684300 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Maria Espinosa Perez |
| Condition | Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2026-04-10 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 250 participants in total. It began in 2026-04-10 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Mar Masiá Canuto, MD, PhD
STUDY CHAIR
Hospital General Universitario de Elche / Universidad Miguel Hernández
Frequently Asked Questions
Who can join the NCT07684300 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07684300 currently recruiting?
Yes, NCT07684300 is actively recruiting participants. Contact the research team at espinosa_mariaper@gva.es for enrollment information.
Where is the NCT07684300 trial being conducted?
This trial is being conducted at Elche, Spain.
Who is sponsoring the NCT07684300 clinical trial?
NCT07684300 is sponsored by Maria Espinosa Perez. The principal investigator is Mar Masiá Canuto, MD, PhD at Hospital General Universitario de Elche / Universidad Miguel Hernández. The trial plans to enroll 250 participants.