Clinical Research Directory

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

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.

Antimicrobial Stewardship Program Implementation in Brazilian Public Hospitals (PeGASUS)

Antimicrobial resistance is a major global public health challenge, leading to increased morbidity, mortality, and healthcare costs. Antimicrobial Stewardship Programs (ASPs) are recognized as an effective strategy to improve the appropriate use of antimicrobials and to reduce the emergence of resistant microorganisms. However, despite national guidelines, many hospitals-especially in low- and middle-income settings-face important barriers to implementing and sustaining these programs. The PeGASUS study is a nationwide, multicenter implementation initiative designed to support and strengthen ASPs in Brazilian public hospitals. The study will include approximately 54 hospitals across all five regions of Brazil that either do not have an ASP or have programs classified as inadequate or basic. This is a pragmatic, quasi-experimental before-and-after study with historical control, conducted over approximately 21 months. The intervention combines multiple strategies to address common implementation barriers, including a structured web-based training program, engagement of hospital leadership, development of locally tailored ASP action plans, ongoing technical support, and collaborative learning between participating hospitals. The study is organized into four phases: (1) pre-intervention (baseline), (2) intervention, (3) follow-up, and (4) wrapping up. During the baseline phase, data on hospital characteristics, antimicrobial use, and ASP organization are collected. During the intervention phase, hospitals receive training and support to implement ASP activities adapted to their local context. The follow-up phase evaluates the sustainability of the implemented strategies under routine conditions. Outcomes include changes in the level of ASP implementation, antimicrobial consumption (measured as defined daily doses per 1,000 patient-days), number and acceptance of stewardship interventions, and clinical outcomes such as length of hospital stay and 30-day mortality. Additionally, a cost-effectiveness analysis will be conducted in a subset of hospitals. All data are collected at the hospital level in aggregated form, without identifying individual patients, ensuring confidentiality and minimizing risks. By combining capacity building, standardized tools, and continuous support, the PeGASUS study aims to bridge the gap between national antimicrobial stewardship guidelines and real-world practice. The findings are expected to provide evidence on scalable strategies to improve antimicrobial use and strengthen healthcare systems, particularly in resource-limited settings.