Impact of Molecular Microbiology Integrated With Clinical Data on Antimicrobial Therapy Optimization: An Open-Label Cluster-Randomized Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Duration of Exposure to High-Impact Antimicrobial Therapy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Duration of Exposure to High-Impact Antimicrobial Therapy
时间窗: 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.
次要结局
- 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)
- Hospital Readmission(Within 10 days after hospital discharge)
- Recurrence of Infection(30 days)
- Healthcare Costs(Up to 5 days after discharge)
- Infection-Related Complications(Up to 30 days after randomization)
研究者
Maria Espinosa Perez
Clinical Investigator
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana