Antimicrobial Stewardship Program Implementation in Brazilian Public Hospitals (PeGASUS) (PeGASUS)

A Nationwide Implementation of Antimicrobial Stewardship Programs in Brazilian Public Hospitals: The PeGASUS Protocol

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Resistance Bacterial; Antimicrobial Stewardship Program
• Intervention / Treatment: Other: ASP implementation

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • São Paulo, São Paulo, Brazil, 01323-020
      • Hospital Alemao Oswaldo Cruz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Public hospitals within the Brazilian Unified Health System (SUS)
• Presence of an established Hospital Infection Prevention and Control (IPC) committee
• Hospitals without an ASP or with an ASP classified as inadequate or basic, according to a standardized ASP assessment tool
• Availability of at least one infectious diseases physician (or physician with expertise in infectious diseases) or a clinical pharmacist with expertise in infectious diseases
• Presence of at least one adult intensive care unit (ICU), including medical, surgical, or coronary ICU
• Institutional agreement and commitment from hospital leadership to participate in the study

Exclusion Criteria:

• Hospitals without formal authorization or agreement from institutional leadership to participate in the study
• Hospitals with adult ICUs currently involved in other antimicrobial stewardship or infection-related intervention studies that could interfere with the outcomes

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: ASP implementation

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Antimicrobial Stewardship Program (ASP) Implementation Level	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.	From enrollment to the end of phase 3 at 20 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antimicrobial Consumption	Antimicrobial consumption will be measured at the hospital level using Defined Daily Dose (DDD) per 1,000 patient-days, stratified by antimicrobial classes. Data will be collected monthly and compared between baseline and post-intervention periods.	Baseline (months 0 to 4) and during intervention and follow-up (months 5-20)
Antimicrobial Stewardship Interventions	This outcome measures the number of interventions performed by the ASP team	Baseline (months 0 to 4) and during intervention and follow-up (months 5-20)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-Day Mortality		Baseline (months 0 to 4) and during intervention and follow-up (months 5-20)
Cost-Effectiveness of ASP Implementation	A cost-effectiveness analysis will be conducted in a subset of hospitals. The analysis will compare pre- and post-intervention periods, incorporating costs related to antimicrobial use, hospitalization, diagnostics, and human resources	Baseline (months 0 to 4) and during intervention and follow-up (months 5-20)

Collaborators and Investigators

• Sponsor: Hospital Alemão Oswaldo Cruz
• Collaborators: ANVISA

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Estimated): September 20, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: March 31, 2026
• First Submitted That Met QC Criteria: March 31, 2026
• First Posted (Actual): April 7, 2026

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 84285924.0.0000.0070

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No