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

NCT07684300 | Recruiting

• 1 other identifier: 2026.002
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Infection; Antimicrobial Stewardship Program; Antimicrobial Resistance; Multiplex PCR

Keywords

Multiplex PCR; Molecular Microbiology; Antimicrobial Stewardship; Antimicrobial Resistance; Antibiotic Optimization; Antimicrobial Therapy; infectious Diseases; Cluster Randomized Trial; Crossover Trial

Outcome Measures

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.

  Up to 30 days after initiation of high-impact antimicrobial therapy

Secondary Outcomes (9)

• Infection-Related Mortality

  30 days

• Antimicrobial-Related Adverse Events

  Up to 30 days after randomization

• Appropriate Antimicrobial Therapy at 24 Hours

  24 hours after randomization

• Appropriate Antimicrobial Therapy at 72 Hours

  72 hours after randomization

• Intensive Care Unit Admission

  Up to 30 days after randomization

Study Arms (2)

Molecular Microbiology-Guided Stewardship

EXPERIMENTAL

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

Standard Antimicrobial Stewardship

ACTIVE COMPARATOR

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

Interventions

Protocolized Antimicrobial Stewardship Strategy BEHAVIORAL

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

Molecular Microbiology-Guided Stewardship

Standard Antimicrobial Stewardship BEHAVIORAL

Routine antimicrobial stewardship practice based on standard clinical assessment and conventional microbiological information.

Standard Antimicrobial Stewardship

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maria Espinosa Perez: lead

Study Sites (1)

Hospital General Universitario de Elche

Elche, Alicante, 03203, Spain

RECRUITING

Related Publications (6)

• Holma T, Torvikoski J, Friberg N, Nevalainen A, Tarkka E, Antikainen J, Martelin JJ. Rapid molecular detection of pathogenic microorganisms and antimicrobial resistance markers in blood cultures: evaluation and utility of the next-generation FilmArray Blood Culture Identification 2 panel. Eur J Clin Microbiol Infect Dis. 2022 Mar;41(3):363-371. doi: 10.1007/s10096-021-04314-2. Epub 2021 Aug 5.

  PMID: 34350523 RESULT

• Murphy CN, Fowler R, Balada-Llasat JM, Carroll A, Stone H, Akerele O, Buchan B, Windham S, Hopp A, Ronen S, Relich RF, Buckner R, Warren DA, Humphries R, Campeau S, Huse H, Chandrasekaran S, Leber A, Everhart K, Harrington A, Kwong C, Bonwit A, Dien Bard J, Naccache S, Zimmerman C, Jones B, Rindlisbacher C, Buccambuso M, Clark A, Rogatcheva M, Graue C, Bourzac KM. Multicenter Evaluation of the BioFire FilmArray Pneumonia/Pneumonia Plus Panel for Detection and Quantification of Agents of Lower Respiratory Tract Infection. J Clin Microbiol. 2020 Jun 24;58(7):e00128-20. doi: 10.1128/JCM.00128-20. Print 2020 Jun 24.

  PMID: 32350043 RESULT

• Moy AC, Kimmoun A, Merkling T, Bercot B, Camelena F, Poncin T, Deniau B, Mebazaa A, Dudoignon E, Depret F; PCR Multiplex Study group (PMS group). Performance evaluation of a PCR panel (FilmArray(R) Pneumonia Plus) for detection of respiratory bacterial pathogens in respiratory specimens: A systematic review and meta-analysis. Anaesth Crit Care Pain Med. 2023 Dec;42(6):101300. doi: 10.1016/j.accpm.2023.101300. Epub 2023 Sep 12.

  PMID: 37709201 RESULT

• Horcajada JP, Grau S, Pano-Pardo JR, Lopez A, Oliver A, Cisneros JM, Rodriguez-Bano J. Antimicrobial stewardship in Spain: Programs for Optimizing the use of Antibiotics (PROA) in Spanish hospitals. Germs. 2018 Sep 3;8(3):109-112. doi: 10.18683/germs.2018.1137. eCollection 2018 Sep. No abstract available.

  PMID: 30250829 RESULT

• Peri AM, Chatfield MD, Ling W, Furuya-Kanamori L, Harris PNA, Paterson DL. Rapid Diagnostic Tests and Antimicrobial Stewardship Programs for the Management of Bloodstream Infection: What Is Their Relative Contribution to Improving Clinical Outcomes? A Systematic Review and Network Meta-analysis. Clin Infect Dis. 2024 Aug 16;79(2):502-515. doi: 10.1093/cid/ciae234.

  PMID: 38676943 RESULT

• Enne VI, Stirling S, Barber JA, High J, Russell C, Brealey D, Dhesi Z, Colles A, Singh S, Parker R, Peters M, Cherian BP, Riley P, Dryden M, Simpson R, Patel N, Cassidy J, Martin D, Welters ID, Page V, Kandil H, Tudtud E, Turner D, Horne R, O'Grady J, Swart AM, Livermore DM, Gant V; INHALE WP3 Study Group and Committees. INHALE WP3, a multicentre, open-label, pragmatic randomised controlled trial assessing the impact of rapid, ICU-based, syndromic PCR, versus standard-of-care on antibiotic stewardship and clinical outcomes in hospital-acquired and ventilator-associated pneumonia. Intensive Care Med. 2025 Feb;51(2):272-286. doi: 10.1007/s00134-024-07772-2. Epub 2025 Feb 17.

  PMID: 39961847 RESULT

MeSH Terms

Conditions

Infections; Communicable Diseases

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  STUDY CHAIR

Central Study Contacts

María Espinosa Pérez, MD

CONTACT

+34 675047622; espinosa_mariaper@gva.es

Sergio Padilla Urrea, MD, PhD

CONTACT

padilla_ser@gva.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Blinding is not feasible because the intervention consists of an antimicrobial stewardship strategy implemented at the hospital-unit level. Investigators and treating clinicians are aware of the assigned strategy, and individual patients are not blinded.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Investigator

Model Details: This is a cluster-randomized crossover trial in which hospital units serve as the clusters. Units are paired according to the type of care provided (conventional hospitalization or critical care) and, within each pair, are randomized to either a protocolized antimicrobial stewardship strategy incorporating multiplex molecular microbiology results and predefined clinical criteria or the standard antimicrobial stewardship strategy. All eligible patients admitted to a unit receive the strategy assigned to that unit. Individual patients are not randomized. Following the initial study period, a washout phase is implemented during which all units follow standard stewardship practice to minimize potential carry-over effects. Units then cross over to the alternate strategy for a second study period. This design allows each participating unit to serve as its own control while reducing the impact of differences in patient populations, case mix, and clinical practice patterns between units.

Study Record Dates

• First Submitted: June 21, 2026
• First Posted: July 6, 2026
• Study Start: April 10, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 6, 2026

Record last verified: 2026-07

Locations

ES (1)