Molecular Microbiology- Guided Antimicrobial Stewardship Versus Standard Stewardship in Hospitalized Patients (PROACT)

July 1, 2026 updated by: Maria Espinosa Perez

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Antimicrobial resistance is one of the greatest challenges facing modern healthcare and is largely driven by inappropriate antimicrobial use. Antimicrobial stewardship programs (ASPs) have become a cornerstone strategy to optimize antimicrobial prescribing and reduce the emergence of antimicrobial resistance. However, antimicrobial decision-making is frequently limited by delays in microbiological diagnosis, often resulting in prolonged exposure to broad-spectrum antimicrobial therapy.

Recent advances in multiplex molecular microbiology allow rapid identification of pathogens and resistance markers directly from clinical samples, frequently several days earlier than conventional microbiological methods. Despite their excellent diagnostic performance, evidence supporting their impact on antimicrobial use and patient outcomes remains inconsistent. Most previous studies have focused on the diagnostic accuracy of these technologies or on their isolated implementation, while the optimal strategy for incorporating molecular results into real-world antimicrobial decision-making remains unclear.

A major unanswered question is not whether multiplex molecular diagnostics can identify microorganisms faster, but how these results should be integrated with clinical and laboratory information to guide antimicrobial prescribing decisions. Current evidence suggests that rapid molecular diagnostics alone may be insufficient to improve outcomes unless they are incorporated into structured antimicrobial stewardship interventions.

The present study addresses this knowledge gap by evaluating an innovative antimicrobial stewardship strategy that combines real-time multiplex molecular microbiology results with predefined clinical and laboratory criteria within an established multidisciplinary ASP. Rather than assessing a diagnostic test in isolation, this study evaluates a standardized decision-making framework designed to translate rapid microbiological information into actionable antimicrobial recommendations.

This is an open-label, pragmatic, cluster-randomized crossover clinical trial conducted at Hospital General Universitario de Elche. Hospital units constitute the clusters and are grouped according to the type of care provided. Clusters are randomized to either the intervention strategy or the standard antimicrobial stewardship strategy during an initial study period.

All eligible patients admitted to a given unit during each study period receive the stewardship strategy assigned to that unit. Individual patients are not randomized.

After completion of the first intervention period, a washout period is implemented to minimize potential carry-over effects. Subsequently, the clusters cross over and receive the alternative stewardship strategy for a second study period. This design allows each participating unit to act as its own control while reducing the impact of differences in patient populations and clinical practice patterns between units.

Eligible participants are hospitalized adults receiving empiric high-impact antimicrobial therapy under ASP supervision. The intervention evaluates whether integrating molecular microbiology into a structured stewardship algorithm enables earlier and more appropriate antimicrobial optimization than conventional stewardship practice.

The primary objective is to determine whether this strategy reduces exposure to high-impact antimicrobial therapy. Secondary objectives include evaluating antimicrobial appropriateness, infection-related outcomes, intensive care unit admission, hospital readmission, recurrence of infection, mortality, adverse events related to antimicrobial therapy, and healthcare costs.

By focusing on the implementation of a standardized stewardship strategy rather than on the diagnostic technology itself, this study seeks to generate clinically relevant evidence regarding how rapid molecular microbiology can be effectively incorporated into routine antimicrobial stewardship programs. The results may contribute to the development of more effective and reproducible antimicrobial optimization strategies and help define the role of molecular diagnostics in everyday clinical practice.

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Molecular Microbiology-Guided Stewardship
Antimicrobial stewardship strategy in which multiplex molecular microbiology results are reviewed in real time and integrated with predefined clinical and laboratory criteria to guide antimicrobial optimization and stewardship recommendations.
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.
Active Comparator: Standard Antimicrobial Stewardship
Standard antimicrobial stewardship strategy based on routine clinical practice, using conventional clinical, laboratory, and microbiological information available to the stewardship team.
Behavioral: Standard Antimicrobial Stewardship
Routine antimicrobial stewardship practice based on standard clinical assessment and conventional microbiological information.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Exposure to High-Impact Antimicrobial Therapy
Time Frame: Up to 30 days after initiation of 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.
Up to 30 days after initiation of high-impact antimicrobial therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infection-Related Mortality
Time Frame: 30 days
Mortality within 30 days in which infection is considered the cause or a contributing factor.
30 days
Antimicrobial-Related Adverse Events
Time Frame: Up to 30 days after randomization
Occurrence of antimicrobial-related adverse events, including Clostridioides difficile infection, allergic reactions, acute kidney injury, hepatotoxicity, and clinically significant drug interactions.
Up to 30 days after randomization
Appropriate Antimicrobial Therapy at 24 Hours
Time Frame: 24 hours after randomization
Proportion of patients receiving appropriate antimicrobial therapy, defined as active therapy against the identified pathogen and the narrowest effective antimicrobial spectrum.
24 hours after randomization
Appropriate Antimicrobial Therapy at 72 Hours
Time Frame: 72 hours after randomization
Proportion of patients receiving appropriate antimicrobial therapy, defined as active therapy against the identified pathogen and the narrowest effective antimicrobial spectrum.
72 hours after randomization
Intensive Care Unit Admission
Time Frame: Up to 30 days after randomization
Requirement for admission to the intensive care unit after randomization among participants not initially admitted to an intensive care unit.
Up to 30 days after randomization
Hospital Readmission
Time Frame: Within 10 days after hospital discharge
Hospital readmission following discharge.
Within 10 days after hospital discharge
Recurrence of Infection
Time Frame: 30 days
Recurrence of infection requiring a new course of antimicrobial therapy.
30 days
Healthcare Costs
Time Frame: Up to 5 days after discharge
Total healthcare costs associated with antimicrobial therapy and multiplex molecular diagnostic testing during the index hospitalization.
Up to 5 days after discharge
Infection-Related Complications
Time Frame: Up to 30 days after randomization
Development of infection-related complications, including abscess formation, empyema, septic shock, or other complications attributable to the index infection.
Up to 30 days after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maria Espinosa Perez

Investigators

  • Study Chair: Mar Masiá Canuto, MD, PhD, Hospital General Universitario de Elche / Universidad Miguel Hernández
  • Study Chair: Félix Gutiérrez Rodero, MD, PhD, Hospital General Universitario de Elche / Universidad Miguel Hernández

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

June 21, 2026

First Submitted That Met QC Criteria

July 1, 2026

First Posted (Actual)

July 6, 2026

Study Record Updates

Last Update Posted (Actual)

July 6, 2026

Last Update Submitted That Met QC Criteria

July 1, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026.002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The investigators have not yet determined whether individual participant data will be shared. Any future data sharing will be considered after study completion, taking into account institutional policies, ethical approvals, and applicable data protection regulations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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