Antimicrobial Stewardship ProgramPeGASUSNCT07514884
Antimicrobial Stewardship Program Implementation in Brazilian Public Hospitals (PeGASUS)
A study testing ASP implementation in people with Antimicrobial Stewardship Program and Resistance Bacterial, run by Hospital Alemão Oswaldo Cruz at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Antimicrobial Stewardship Program, Resistance Bacterial
- What is being tested?
- ASP implementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2025to 1 Oct 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Being tested
- ASP implementation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP implementationOther
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 group | Role | What they receive |
|---|---|---|
| ASP implementation | Other | ASP implementation Receives: Other: ASP implementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of phase 3 at 20 months
Secondary outcomes (2)
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.
Measured: 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
Measured: Baseline (months 0 to 4) and during intervention and follow-up (months 5-20)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start1 Mar 2025
- Primary completion20 Sep 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antimicrobial Stewardship ProgramStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Alemão Oswaldo Cruz
- Sponsor type
- University, hospital or other
- Collaborators
- ANVISA
- Responsible party
- Principal investigator, Filipe Teixeira Piastrelli, Hospital Alemão Oswaldo Cruz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07514884
- Sponsor's protocol ID
- 84285924.0.0000.0070
- Acronym
- PeGASUS
- Status last verified
- Mar 2026
- First submitted
- 31 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nationwide Implementation of Antimicrobial Stewardship Programs in Brazilian Public Hospitals: The PeGASUS Protocol
- ClinicalTrials.gov ID
- NCT07514884
- Acronym / sponsor ID
- PeGASUS / 84285924.0.0000.0070
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Hospital Alemão Oswaldo CruzUniversity, hospital or other
- Collaborators
- ANVISA
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 20 Sep 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 7 Apr 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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASP implementation | Other | Other: ASP implementationASP implementation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| ASP implementationThe 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. | Other | ASP implementation |
Primary outcome
Change in Antimicrobial Stewardship Program (ASP) Implementation Level
Time frame: 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.
2 secondary outcomes
Antimicrobial Consumption
Time frame: Baseline (months 0 to 4) and during intervention and follow-up (months 5-20)
Antimicrobial Stewardship Interventions
Time frame: Baseline (months 0 to 4) and during intervention and follow-up (months 5-20)
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 7 Apr 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ASP implementation in people with Antimicrobial Stewardship Program and Resistance Bacterial, run by Hospital Alemão Oswaldo Cruz at 1 site in Brazil.
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 6 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 7 Apr 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 Brazil. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Antimicrobial Stewardship Program (ASP) Implementation Level (time frame: From enrollment to the end of phase 3 at 20 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Apr 2026.