InfectionPROACTNCT07684300
Molecular Microbiology- Guided Antimicrobial Stewardship Versus Standard Stewardship in Hospitalized Patients
A study testing Protocolized Antimicrobial Stewardship Strategy and Standard Antimicrobial Stewardship in people with Infection and Antimicrobial Stewardship Program, run by Maria Espinosa Perez at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection, Antimicrobial Stewardship Program, Antimicrobial Resistance
- What is being tested?
- Protocolized Antimicrobial Stewardship Strategy and Standard Antimicrobial Stewardship
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteSpain
- Study dates
- 10 Apr 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sergio Padilla Urrea, MD, PhD contact
Spain1 site, 1 recruiting
- Recruiting
Hospital General Universitario de Elche
Elche, Alicante, 03203
Maria Espinosa Pérez, (+34) 966 616 754, espinosa_mariaper@gva.es
Leandro Lopez Gutiérrez, leandro.lopez@fisabio.es
About this study
Official title: 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:
Read more
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.
Read the 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.
- Being tested
- Protocolized Antimicrobial Stewardship Strategy, Standard Antimicrobial Stewardship
- Keywords
- Multiplex PCR, Molecular Microbiology, Antimicrobial Stewardship, Antimicrobial Resistance, Antibiotic Optimization, Antimicrobial Therapy, infectious Diseases, Cluster Randomized Trial, Crossover Trial
- Medical subject headings
- Infections, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protocolized Antimicrobial Stewardship StrategyBehavioural
A standardized antimicrobial stewardship strategy integrating multiplex molecular microbiology results with predefined clinical and laboratory criteria to support antimicrobial prescribing decisions.
Standard Antimicrobial StewardshipBehavioural
Routine antimicrobial stewardship practice based on standard clinical assessment and conventional microbiological information.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standard Antimicrobial Stewardship |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 30 days after initiation of high-impact antimicrobial therapy
Secondary outcomes (9)
Infection-Related Mortality
Mortality within 30 days in which infection is considered the cause or a contributing factor.
Measured: 30 days
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.
Measured: Up to 30 days after randomization
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.
Measured: 24 hours after randomization
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.
Measured: 72 hours after randomization
Intensive Care Unit Admission
Requirement for admission to the intensive care unit after randomization among participants not initially admitted to an intensive care unit.
Measured: Up to 30 days after randomization
Hospital Readmission
Hospital readmission following discharge.
Measured: Within 10 days after hospital discharge
Recurrence of Infection
Recurrence of infection requiring a new course of antimicrobial therapy.
Measured: 30 days
Healthcare Costs
Total healthcare costs associated with antimicrobial therapy and multiplex molecular diagnostic testing during the index hospitalization.
Measured: Up to 5 days after discharge
Infection-Related Complications
Development of infection-related complications, including abscess formation, empyema, septic shock, or other complications attributable to the index infection.
Measured: Up to 30 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start10 Apr 2026
- Primary completionApr 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maria Espinosa Perez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Maria Espinosa Perez, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
- Investigators
- Mar Masiá Canuto, MD, PhD, Study chair, Hospital General Universitario de Elche / Universidad Miguel HernándezFélix Gutiérrez Rodero, MD, PhD, Study chair, Hospital General Universitario de Elche / Universidad Miguel Hernández
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07684300
- Sponsor's protocol ID
- 2026.002
- Acronym
- PROACT
- Status last verified
- Jul 2026
- First submitted
- 21 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
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.
PubMed 34350523Murphy 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.
PubMed 32350043Moy 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.
PubMed 37709201Horcajada 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.
PubMed 30250829Peri 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.
PubMed 38676943Enne 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.
PubMed 39961847
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Molecular Microbiology Integrated With Clinical Data on Antimicrobial Therapy Optimization: An Open-Label Cluster-Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT07684300
- Acronym / sponsor ID
- PROACT / 2026.002
- Keywords
- Multiplex PCR, Molecular Microbiology, Antimicrobial Stewardship, Antimicrobial Resistance, Antibiotic Optimization, Antimicrobial Therapy, infectious Diseases, Cluster Randomized Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Maria Espinosa PerezUniversity, hospital or other
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Molecular Microbiology-Guided Stewardship | Experimental | Behavioral: Protocolized Antimicrobial Stewardship StrategyAntimicrobial 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. |
| Standard Antimicrobial Stewardship | Active comparator | Behavioral: Standard Antimicrobial StewardshipStandard antimicrobial stewardship strategy based on routine clinical practice, using conventional clinical, laboratory, and microbiological information available to the stewardship team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protocolized Antimicrobial Stewardship StrategyA standardized antimicrobial stewardship strategy integrating multiplex molecular microbiology results with predefined clinical and laboratory criteria to support antimicrobial prescribing decisions. | Behavioural | Molecular Microbiology-Guided Stewardship |
| Standard Antimicrobial StewardshipRoutine antimicrobial stewardship practice based on standard clinical assessment and conventional microbiological information. | Behavioural | Standard Antimicrobial Stewardship |
Primary outcome
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.
9 secondary outcomes
Infection-Related Mortality
Time frame: 30 days
Antimicrobial-Related Adverse Events
Time frame: Up to 30 days after randomization
Appropriate Antimicrobial Therapy at 24 Hours
Time frame: 24 hours after randomization
Appropriate Antimicrobial Therapy at 72 Hours
Time frame: 72 hours after randomization
Intensive Care Unit Admission
Time frame: Up to 30 days after randomization
Hospital Readmission
Time frame: Within 10 days after hospital discharge
Recurrence of Infection
Time frame: 30 days
Healthcare Costs
Time frame: Up to 5 days after discharge
Infection-Related Complications
Time frame: Up to 30 days after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Results publication: PubMed 34350523Holma 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.
- Results publication: PubMed 32350043Murphy 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.
- Results publication: PubMed 37709201Moy 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.
- Results publication: PubMed 30250829Horcajada 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.
- Results publication: PubMed 38676943Peri 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.
- Results publication: PubMed 39961847Enne 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.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sergio Padilla Urrea, MD, PhD contact
Mar Masiá Canuto, MD, PhD study chair
Hospital General Universitario de Elche / Universidad Miguel Hernández
Félix Gutiérrez Rodero, MD, PhD study chair
Hospital General Universitario de Elche / Universidad Miguel Hernández
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protocolized Antimicrobial Stewardship Strategy and Standard Antimicrobial Stewardship in people with Infection and Antimicrobial Stewardship Program, run by Maria Espinosa Perez at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact María Espinosa Pérez, MD (+34 675047622, espinosa_mariaper@gva.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Exposure to High-Impact Antimicrobial Therapy (time frame: Up to 30 days after initiation of high-impact antimicrobial therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07684300, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.