Antimicrobial Stewardship Program Implementation in Brazilian Public Hospitals (PeGASUS)

Condition(s) studied

Investigational drug(s) / intervention(s)

ASP implementation: The PeGASUS intervention is a multifaceted implementation strategy to support the development of Antimicrobial Stewardship Programs (ASPs) in Brazilian public hospitals. Delivered over 10 months, it combines: (1) a structured web-based training program with five modules; (2) development of a locally tailored ASP implementation plan based on national guidelines; (3) engagement of hospital leadership and formation of multidisciplinary ASP teams; (4) ongoing technical support through monthly virtual meetings and at least one on-site visit; (5) collaborative learning and benchmarking sessions across hospitals; and (6) standardized monitoring of antimicrobial use and stewardship activities. This intervention integrates education, mentorship, and locally adapted implementation strategies, aiming to enable hospitals with limited resources to transition from passive antimicrobial monitoring to active stewardship practices.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Change in Antimicrobial Stewardship Program (ASP) Implementation Level — From enrollment to the end of phase 3 at 20 months
  The primary outcome is the change in the organizational level of Antimicrobial Stewardship Programs (ASPs) at the hospital level, measured using a standardized ASP Implementation Level Assessment Questionnaire. This tool classifies hospitals into predefined categories (nonexistent, inadequate, basic, intermediate, or advanced) based on the presence and maturity of core stewardship components. The outcome will be assessed by comparing baseline and post-intervention classifications within each hospital. Changes in ASP level will be analyzed using paired statistical methods, and improvement rates will be reported. This outcome reflects the effectiveness of the intervention in strengthening ASP structure and implementation capacity.

Trial sites (1)

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