InfectionSAFE-REDUCENCT07093450
Quality Improvement Intervention for a Safe Antimicrobial Use Reduction in Critically Ill Patients
A study testing Educational Quality Improvement Intervention in people with Infection and Antimicrobial Stewardship, run by Hospital Sirio-Libanes at 9 sites in Brazil.
Trial summary
The goal of this clinical trial is to learn if an educational intervention with audit and feedback on physicians and health care professionals who participate in antimicrobial treatment decisions can reduce the use of antimicrobials in adult patients admitted to a sample of Brazilian intensive care units (ICUs). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection, Antimicrobial Stewardship, Critically Ill Intensive Care Unit Patients
- What is being tested?
- Educational Quality Improvement Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9,000 participants
- Where
- 9 sitesBrazil
- Study dates
- 1 Jun 2025to Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Intensive care units inclusion Criteria:
- ICU leadership acceptance to participant in the quality improvement intervention;
- Hospital infection control leadership acceptance to participant in the quality improvement intervention;
- ICU participation in the IMPACTO-MR platform with high quality data;
- ICU potential for quality improvement based on a subjective assessment of the ICU and hospital infection leaderships
Intensive care units exclusion Criteria:
- Absence of local IRB approval
Participants inclusion Criteria:
- All patients admitted to the intensive care unit
Participants exclusion Criteria:
- Patients younger than 18 years-old will be excluded from individual-level analysis
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Bruno M Tomazini contact
9 sites in 1 country
Brazil9 sites, 9 recruiting
- Recruiting
Santa Casa de Misericórdia de Barretos
Barretos, São Paulo
Isaac F D Favaro, +55 17 98119-7004, isaacdelfavero@hotmail.com
- Recruiting
Hospital Maternidade São José
Colatina, Espírito Santo
Rodrigo C Figueiredo, +55 27 98898-0486, figueiredorc@hotmail.com
- Recruiting
Hospital Municipal de Maringá
Maringá, Paraná
Ana Cristina M Gurgel, +55 44 9103-5071, anacrismed@yahoo.com.br
- Recruiting
Hospital Onofre Lopes
Natal, Rio Grande do Norte
Gisele R Borba, + 55 84 8144-8666, gisele.borba@ebserh.gov.br
- Recruiting
Santa Casa de Misericórdia de Passos
Passos, Minas Gerais
Priscila F N Gonçalves, +55 35 8882-9688, prifreitas@yahoo.com.br
- Recruiting
Hospital de Pronto Socorro
Porto Alegre, Rio Grande do Sul
Cristiano A Franke, +55 51 9933-0031, cristianofranke@gmail.com
- Recruiting
Hospital Pelópidas Silveira
Recife, Pernambuco
Lívia A Medeiros, +55 81 9178-3913, liviamedeiros@hotmail.com
- Recruiting
Hospital Naval Marcílio Dias
Rio de Janeiro, Rio de Janeiro
Vitor A Borges, +55 21 97459-7222, borges.vitor@marinha.mil.br
- Recruiting
Hospital Santa Cruz
Santa Cruz do Sul, Rio Grande do Sul
Maitê S Magdalena, +55 51 9737-4979, maitemagdalena@unisc.br
About this study
Official title: Estudo de Implementação de Melhoria de Qualidade Para Redução do Uso de Antimicrobianos em Unidades de Terapia Intensiva
The goal of this clinical trial is to learn if an educational intervention with audit and feedback on physicians and health care professionals who participate in antimicrobial treatment decisions can reduce the use of antimicrobials in adult patients admitted to a sample of Brazilian intensive care units (ICUs). The educational intervention is based on a literature review of current recommendations for a more rational use of antimicrobials and microbiological tests in daily ICU practice.
The main questions it aims to answer are:
Read more
- Does the educational intervention reduce the antimicrobial consumption in the intensive care units?
- Does this educational intervention aiming to reduce antimicrobial utilization in accordance with the latest guidelines have any safety signals regarding ICU mortality rates or ICU length-of-stay?
Researchers will compare (1) ICUs sequentially randomized to this quality improvement educational intervention aimed at improving antimicrobial utilization to (2) the same ICUs at months where the educational intervention has not been delivered yet.
Each participant ICU will transition to the quality improvement intervention approximately each month, starting at July, 2025. This quality improvement intervention is based on current recommendations for antimicrobial stewardship from regulatory agencies and medical societies, including cognitive aids for physicians to improve decision-making regarding the commencement of antimicrobials, their duration and antimicrobial time-outs. The investigators hypothesize that intensivists (ICU doctors) need to embrace antimicrobial stewardship as a core competence of their daily activities.
Read the detailed description
The SAFE-REDUCE trial is a hybrid effectiveness-implementation type 1 trial, where the investigators intend to implement a quality improvement (QI) intervention aiming to improve antimicrobial utilization in a sample of intensive care units. Their hypothesis is that this QI intervention will reduce antimicrobial consumption in the studied intensive care units. For this implementation, due to logistical constraints, the investigators can only train one intensive care unit at a time and therefore they designed a stepped-wedge cluster randomized trial to evaluate the impact of this QI intervention.
The trial will be conducted in 10 intensive care units currently participating in the IMPACTO-MR platform, a registry focused on evaluating the impact of intensive care unit acquired infections and multidrug resistant infections. IMPACTO-MR routinely collects data from the participating ICUs, including standard ICU quality improvement data. Additionally, the platform collects data on antimicrobial utilization, reported ICU-acquired infections and microbiological culture results. In the SAFE-REDUCE trial, the investigators will take advantage of this ongoing registry to test if the educational QI intervention can modulate antimicrobial utilization while maintaining the trends of ICU mortality and length-of-stay.
Each participant ICU will go through a control phase, in which they will follow their current practice, and they will be transitioned to an intervention phase, in which the quality improvement intervention will be delivered to the intensive care unit.
The QI intervention will provide cognitive aids to ICU physicians aiming at improving their decision-making for antimicrobial initiation, antimicrobial time-outs (i.e, routine revisions of the actual need for antimicrobials) and, when an infection is highly likely, deciding appropriate, shorter durations of antimicrobials. The investigators will provide intensive care units with educational sessions, a written guide for antimicrobial initiation and duration decision-making, while also accounting for key diagnostic stewardship considerations. Following an initial site visit, the investigators will collect monthly point-prevalence surveys in the ICUs regarding antimicrobial utilization in one day of the month, for the duration of the trial. During these point-prevalence surveys, feedback will be provided to the ICU provider to be delivered to the ICU team. Additionally, during the first site visit, ICUs will be encouraged to evaluate barriers and facilitators to implement the educational intervention in their units, and they will be allowed to adapt further local training based on this assessment.
All participating ICUs of the SAFE-REDUCE stepped-wedge cluster randomized trial will be transitioned to the quality improvement intervention. The investigators included a baseline period (one month before implementation, expected on June, 2025, where only routinely collected data from the IMPACTO-MR platform will be linked to SAFE-REDUCE) in all ICUs and a phase-out phase (for three months, expected to occur on May-Jul, 2026) to evaluate whether any intervention benefits sustain after the investigators stop the point-prevalence surveys and feedback.
The investigators calculated sample size based on Hemming et al. suggested method. Considering that the study ICUs screened for participating in the SAFE-REDUCE trial would have between 10 and 30 ICU beds, most of them with 20 ICU beds, assuming a conservative occupation rate of 85%, the investigators estimated that 600 patient-days per period would be included, with each participating ICU transitioning to the intervention period in 10 steps. The investigators estimate the intervention will be able to reduce up to 20% the antimicrobial consumption in the ICU and they anticipate a variable baseline rate of antimicrobial utilization, considering an intracluster correlation coefficient (ICC) of 0.1. The investigators tested different ICCs, baseline daily defined doses and reductions in their level and the sample size yielded > 90% power in all simulations.
Given the analysis at the cluster level, informed consent was waived from the institutional review board at the coordinating center and at each participating hospital institutional review boards. They agreed with a minimal risk study (i.e., participation in this study will not incur higher risk than usual random variability observed in clinical practice) and the impossibility of obtaining informed consent to withdraw data utilization, as the primary outcome data is collected at the level of the unit, not at the level of the participants.
- Being tested
- Educational Quality Improvement Intervention
- Keywords
- Antimicrobial stewardship, Intensive care unit, Infection, Stepped-wedge cluster trials, Hybrid effectiveness-implementation trials, Diagnostic stewardship
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational Quality Improvement InterventionOther
The intervention will be delivered at the cluster level. It will include an initiation visit, when educational sessions and an operations manual will be delivered to the ICU. These will consist of cognitive aids for antimicrobial initiation and duration decision-making, based on recent recommendations from guidelines, societies and regulatory authorities. In this visit, an assessment of barriers and facilitators for implementation of the behavioral change will be done, so that local adaptations can be done by the clinicians championing the implementation. Additionally, monthly, one-day audits will be done, which will be used to provide feedback to the ICU during the intervention phase regarding the suggested recommendations for antimicrobial decision-making.
| Study group | Role | What they receive |
|---|---|---|
| ICU Standard-of-care | No intervention | The control group will be before the quality improvement intervention. Each ICU will be their own control and also the control group for ICUs that have already transitioned to the quality improvement arm. During this period, before transitioning to the educational QI intervention, ICUs will continue their routine standard-of-care, including any ongoing continuous quality improvement that takes part of the usual ICU management activities. Local ICUs have been disencouraged, though, to start any quality improvement initiatives aiming to improve antimicrobial consumption before their transition to the intervention phase. |
| Educational Quality Improvement Intervention | Experimental | Participant ICUs who have transitioned to the quality improvement intervention will be part of this arm after their first visit. The intervention will consist of cognitive aids regarding antimicrobial initiation and duration for ICU physicians and healthcare professionals involved with antimicrobial decision-making. There will also be a monthly cross-sectional evaluation of the fidelity of the intervention, with immediate feedback at each assessment to the participating ICU. Receives: Other: Educational Quality Improvement Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antimicrobial utilization at the ICU level
Antimicrobial utilization will be measured as daily defined doses (DDD) of antimicrobials at the ICU level per 100 patient-days
Measured: 14 months
Secondary outcomes (2)
ICU mortality rate
ICU mortality rate adjusted for illness severity at baseline (measured with the illness severity score SAPS 3)
Measured: 14 months
ICU length-of-stay
ICU length-of-stay, adjusted for baseline illness severity (SAPS 3)
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start1 Jun 2025
- Primary completionApr 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The study is a stepped-wedge cluster randomized trial, in which each of the 10 intensive care units will be randomized to receive a quality improvement intervention at each month. They will know about their allocation with 1-2 months preceding the commencement of the quality improvement intervention. There will be no transition period for the primary analysis. As the study is at the cluster level, no blinding will be possible.
- Masking
- None (open label)
- Enrolment
- 9,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Sirio-Libanes
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital do Coracao, Hospital Israelita Albert Einstein, Beneficência Portuguesa de São Paulo
- Responsible party
- Sponsor
- Investigators
- Bruno A M P Besen, M.D., Ph.D., Principal investigator, Hospital Sirio-Libanes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07093450
- Sponsor's protocol ID
- 85063424.0.1001.5461
- Acronym
- SAFE-REDUCE
- Status last verified
- Jul 2025
- First submitted
- 16 Jun 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual patient data (IPD) might be shared upon request and approval by the study steering committee after the study completion.
Publications
Tomazini BM, Nassar AP Jr, Lisboa TC, Azevedo LCP, Veiga VC, Catarino DGM, Fogazzi DV, Arns B, Piastrelli FT, Dietrich C, Negrelli KL, Jesuino IA, Reis LFL, Mattos RR, Pinheiro CCG, Luz MN, Spadoni CCDS, Moro EE, Bueno FR, Sampaio CSJC, Silva DP, Baldassare FP, Silva ACA, Veiga T, Barbante L, Lambauer M, Campos VB, Santos E, Santos RHN, Laranjeiras LN, Valeis N, Santucci E, Miranda TA, Patrocinio ACLD, Carvalho A, Sousa EMC, Sousa AHF, Malheiro DT, Bezerra IL, Rodrigues MB, Malicia JC, Silva SSD, Gimenes BDP, Sesin GP, Zavascki AP, Sganzerla D, Medeiros GS, Santos RDRMD, Silva FKR, Cheno MY, Abrahao CF, Oliveira Junior HA, Rocha LL, Nunes Neto PA, Pereira VC, Paciencia LEM, Bueno ES, Caser EB, Ribeiro LZ, Fernandes CCF, Garcia JM, Silva VFF, Santos AJD, Machado FR, Souza MA, Ferronato BR, Urbano HCA, Moreira DCA, Souza-Dantas VC, Duarte DM, Coelho J, Figueiredo RC, Foreque F, Romano TG, Cubos D, Spirale VM, Nogueira RS, Maia IS, Zandonai CL, Lovato WJ, Cerantola RB, Toledo TGP, Tomba PO, Almeida JR, Sanches LC, Pierini L, Cunha M, Sousa MT, Azevedo B, Dal-Pizzol F, Damasio DC, Bainy MP, Beduhn DAV, Jatoba JDVN, Moura MTF, Rego LRM, Silva AVD, Oliveira LP, Sodre Filho ES, Santos SSD, Neves IL, Leao VCA, Paes JLL, Silva MCM, Oliveira CD, Santiago RCB, Paranhos JLDR, Wiermann IGDS, Pedroso DFF, Sawada PY, Prestes RM, Nascimento GC, Grion CMC, Carrilho CMDM, Dantas RLAM, Silva EP, Silva ACD, Oliveira SMB, Golin NA, Tregnago R, Lima VP, Silva KGND, Boschi E, Buffon V, Machado AS, Capeletti L, Foernges RB, Carvalho AS, Oliveira Junior LC, Oliveira DC, Silva EM, Ribeiro J, Pereira FC, Salgado FB, Deutschendorf C, Silva CFD, Gobatto ALN, Oliveira CB, Dracoulakis MDA, Alvaia NOS, Souza RM, Araujo LLC, Melo RMV, Passos LCS, Vidal CFL, Rodrigues FLA, Kurtz P, Shinotsuka CR, Tavares MB, Santana IDV, Gavinho LMDS, Nascimento AB, Pereira AJ, Cavalcanti AB. IMPACTO-MR: a Brazilian nationwide platform study to assess infections and multidrug resistance in intensive care units. Rev Bras Ter Intensiva. 2022 Oct-Dec;34(4):418-425. doi: 10.5935/0103-507X.20220209-pt. Epub 2023 Mar 3.
PubMed 36888821
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estudo de Implementação de Melhoria de Qualidade Para Redução do Uso de Antimicrobianos em Unidades de Terapia Intensiva
- ClinicalTrials.gov ID
- NCT07093450
- Acronym / sponsor ID
- SAFE-REDUCE / 85063424.0.1001.5461
- Keywords
- Antimicrobial stewardship, Intensive care unit, Infection, Stepped-wedge cluster trials, Hybrid effectiveness-implementation trials, Diagnostic stewardship
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9,000 participants (estimated)
- Lead sponsor
- Hospital Sirio-LibanesUniversity, hospital or other
- Collaborators
- Hospital do Coracao, Hospital Israelita Albert Einstein, Beneficência Portuguesa de São Paulo
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 30 Jul 2025 (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.
The goal of this clinical trial is to learn if an educational intervention with audit and feedback on physicians and health care professionals who participate in antimicrobial treatment decisions can reduce the use of antimicrobials in adult patients admitted to a sample of Brazilian intensive care units (ICUs). The educational intervention is based on a literature review of current recommendations for a more rational use of antimicrobials and microbiological tests in daily ICU practice.
The main questions it aims to answer are:
- Does the educational intervention reduce the antimicrobial consumption in the intensive care units?
- Does this educational intervention aiming to reduce antimicrobial utilization in accordance with the latest guidelines have any safety signals regarding ICU mortality rates or ICU length-of-stay?
Researchers will compare (1) ICUs sequentially randomized to this quality improvement educational intervention aimed at improving antimicrobial utilization to (2) the same ICUs at months where the educational intervention has not been delivered yet.
Each participant ICU will transition to the quality improvement intervention approximately each month, starting at July, 2025. This quality improvement intervention is based on current recommendations for antimicrobial stewardship from regulatory agencies and medical societies, including cognitive aids for physicians to improve decision-making regarding the commencement of antimicrobials, their duration and antimicrobial time-outs. The investigators hypothesize that intensivists (ICU doctors) need to embrace antimicrobial stewardship as a core competence of their daily activities.
Detailed description
The SAFE-REDUCE trial is a hybrid effectiveness-implementation type 1 trial, where the investigators intend to implement a quality improvement (QI) intervention aiming to improve antimicrobial utilization in a sample of intensive care units. Their hypothesis is that this QI intervention will reduce antimicrobial consumption in the studied intensive care units. For this implementation, due to logistical constraints, the investigators can only train one intensive care unit at a time and therefore they designed a stepped-wedge cluster randomized trial to evaluate the impact of this QI intervention.
The trial will be conducted in 10 intensive care units currently participating in the IMPACTO-MR platform, a registry focused on evaluating the impact of intensive care unit acquired infections and multidrug resistant infections. IMPACTO-MR routinely collects data from the participating ICUs, including standard ICU quality improvement data. Additionally, the platform collects data on antimicrobial utilization, reported ICU-acquired infections and microbiological culture results. In the SAFE-REDUCE trial, the investigators will take advantage of this ongoing registry to test if the educational QI intervention can modulate antimicrobial utilization while maintaining the trends of ICU mortality and length-of-stay.
Each participant ICU will go through a control phase, in which they will follow their current practice, and they will be transitioned to an intervention phase, in which the quality improvement intervention will be delivered to the intensive care unit.
The QI intervention will provide cognitive aids to ICU physicians aiming at improving their decision-making for antimicrobial initiation, antimicrobial time-outs (i.e, routine revisions of the actual need for antimicrobials) and, when an infection is highly likely, deciding appropriate, shorter durations of antimicrobials. The investigators will provide intensive care units with educational sessions, a written guide for antimicrobial initiation and duration decision-making, while also accounting for key diagnostic stewardship considerations. Following an initial site visit, the investigators will collect monthly point-prevalence surveys in the ICUs regarding antimicrobial utilization in one day of the month, for the duration of the trial. During these point-prevalence surveys, feedback will be provided to the ICU provider to be delivered to the ICU team. Additionally, during the first site visit, ICUs will be encouraged to evaluate barriers and facilitators to implement the educational intervention in their units, and they will be allowed to adapt further local training based on this assessment.
All participating ICUs of the SAFE-REDUCE stepped-wedge cluster randomized trial will be transitioned to the quality improvement intervention. The investigators included a baseline period (one month before implementation, expected on June, 2025, where only routinely collected data from the IMPACTO-MR platform will be linked to SAFE-REDUCE) in all ICUs and a phase-out phase (for three months, expected to occur on May-Jul, 2026) to evaluate whether any intervention benefits sustain after the investigators stop the point-prevalence surveys and feedback.
The investigators calculated sample size based on Hemming et al. suggested method. Considering that the study ICUs screened for participating in the SAFE-REDUCE trial would have between 10 and 30 ICU beds, most of them with 20 ICU beds, assuming a conservative occupation rate of 85%, the investigators estimated that 600 patient-days per period would be included, with each participating ICU transitioning to the intervention period in 10 steps. The investigators estimate the intervention will be able to reduce up to 20% the antimicrobial consumption in the ICU and they anticipate a variable baseline rate of antimicrobial utilization, considering an intracluster correlation coefficient (ICC) of 0.1. The investigators tested different ICCs, baseline daily defined doses and reductions in their level and the sample size yielded > 90% power in all simulations.
Given the analysis at the cluster level, informed consent was waived from the institutional review board at the coordinating center and at each participating hospital institutional review boards. They agreed with a minimal risk study (i.e., participation in this study will not incur higher risk than usual random variability observed in clinical practice) and the impossibility of obtaining informed consent to withdraw data utilization, as the primary outcome data is collected at the level of the unit, not at the level of the participants.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is a stepped-wedge cluster randomized trial, in which each of the 10 intensive care units will be randomized to receive a quality improvement intervention at each month. They will know about their allocation with 1-2 months preceding the commencement of the quality improvement intervention. There will be no transition period for the primary analysis. As the study is at the cluster level, no blinding will be possible.
| Arm | Type | Receives |
|---|---|---|
| ICU Standard-of-care | No intervention | –The control group will be before the quality improvement intervention. Each ICU will be their own control and also the control group for ICUs that have already transitioned to the quality improvement arm. During this period, before transitioning to the educational QI intervention, ICUs will continue their routine standard-of-care, including any ongoing continuous quality improvement that takes part of the usual ICU management activities. Local ICUs have been disencouraged, though, to start any quality improvement initiatives aiming to improve antimicrobial consumption before their transition to the intervention phase. |
| Educational Quality Improvement Intervention | Experimental | Other: Educational Quality Improvement InterventionParticipant ICUs who have transitioned to the quality improvement intervention will be part of this arm after their first visit. The intervention will consist of cognitive aids regarding antimicrobial initiation and duration for ICU physicians and healthcare professionals involved with antimicrobial decision-making. There will also be a monthly cross-sectional evaluation of the fidelity of the intervention, with immediate feedback at each assessment to the participating ICU. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Educational Quality Improvement InterventionThe intervention will be delivered at the cluster level. It will include an initiation visit, when educational sessions and an operations manual will be delivered to the ICU. These will consist of cognitive aids for antimicrobial initiation and duration decision-making, based on recent recommendations from guidelines, societies and regulatory authorities. In this visit, an assessment of barriers and facilitators for implementation of the behavioral change will be done, so that local adaptations can be done by the clinicians championing the implementation. Additionally, monthly, one-day audits will be done, which will be used to provide feedback to the ICU during the intervention phase regarding the suggested recommendations for antimicrobial decision-making. | Other | Educational Quality Improvement Intervention |
Primary outcome
Antimicrobial utilization at the ICU level
Time frame: 14 months
Antimicrobial utilization will be measured as daily defined doses (DDD) of antimicrobials at the ICU level per 100 patient-days
2 secondary outcomes
ICU mortality rate
Time frame: 14 months
ICU length-of-stay
Time frame: 14 months
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 3 Dec 2025.
- Results publication: PubMed 36888821Tomazini BM, Nassar AP Jr, Lisboa TC, Azevedo LCP, Veiga VC, Catarino DGM, Fogazzi DV, Arns B, Piastrelli FT, Dietrich C, Negrelli KL, Jesuino IA, Reis LFL, Mattos RR, Pinheiro CCG, Luz MN, Spadoni CCDS, Moro EE, Bueno FR, Sampaio CSJC, Silva DP, Baldassare FP, Silva ACA, Veiga T, Barbante L, Lambauer M, Campos VB, Santos E, Santos RHN, Laranjeiras LN, Valeis N, Santucci E, Miranda TA, Patrocinio ACLD, Carvalho A, Sousa EMC, Sousa AHF, Malheiro DT, Bezerra IL, Rodrigues MB, Malicia JC, Silva SSD, Gimenes BDP, Sesin GP, Zavascki AP, Sganzerla D, Medeiros GS, Santos RDRMD, Silva FKR, Cheno MY, Abrahao CF, Oliveira Junior HA, Rocha LL, Nunes Neto PA, Pereira VC, Paciencia LEM, Bueno ES, Caser EB, Ribeiro LZ, Fernandes CCF, Garcia JM, Silva VFF, Santos AJD, Machado FR, Souza MA, Ferronato BR, Urbano HCA, Moreira DCA, Souza-Dantas VC, Duarte DM, Coelho J, Figueiredo RC, Foreque F, Romano TG, Cubos D, Spirale VM, Nogueira RS, Maia IS, Zandonai CL, Lovato WJ, Cerantola RB, Toledo TGP, Tomba PO, Almeida JR, Sanches LC, Pierini L, Cunha M, Sousa MT, Azevedo B, Dal-Pizzol F, Damasio DC, Bainy MP, Beduhn DAV, Jatoba JDVN, Moura MTF, Rego LRM, Silva AVD, Oliveira LP, Sodre Filho ES, Santos SSD, Neves IL, Leao VCA, Paes JLL, Silva MCM, Oliveira CD, Santiago RCB, Paranhos JLDR, Wiermann IGDS, Pedroso DFF, Sawada PY, Prestes RM, Nascimento GC, Grion CMC, Carrilho CMDM, Dantas RLAM, Silva EP, Silva ACD, Oliveira SMB, Golin NA, Tregnago R, Lima VP, Silva KGND, Boschi E, Buffon V, Machado AS, Capeletti L, Foernges RB, Carvalho AS, Oliveira Junior LC, Oliveira DC, Silva EM, Ribeiro J, Pereira FC, Salgado FB, Deutschendorf C, Silva CFD, Gobatto ALN, Oliveira CB, Dracoulakis MDA, Alvaia NOS, Souza RM, Araujo LLC, Melo RMV, Passos LCS, Vidal CFL, Rodrigues FLA, Kurtz P, Shinotsuka CR, Tavares MB, Santana IDV, Gavinho LMDS, Nascimento AB, Pereira AJ, Cavalcanti AB. IMPACTO-MR: a Brazilian nationwide platform study to assess infections and multidrug resistance in intensive care units. Rev Bras Ter Intensiva. 2022 Oct-Dec;34(4):418-425. doi: 10.5935/0103-507X.20220209-pt. Epub 2023 Mar 3.
- Individual participant dataSharing planned: Yes. Individual patient data (IPD) might be shared upon request and approval by the study steering committee after the study completion.
Related trials for Infection
RecruitingPhase 2/3
A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005)
B-cell Acute Lymphoblastic Leukemia
Recruiting
Comparison of Uncomplicated Candidemia Therapy Duration in Children and Adults
Invasive Candidiasis
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Not yet recruitingObservational study
Arterial Stiffness During Negative Pressure Wound Therapy for Abdominal Wall Wounds
Postoperative Abdominal Wall Wound Complications, Surgical Wound Infection
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
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.
Bruno M Tomazini contact
Bruno A M P Besen, M.D., Ph.D. principal investigator
Hospital Sirio-Libanes
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Quality Improvement Intervention in people with Infection and Antimicrobial Stewardship, run by Hospital Sirio-Libanes at 9 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: looking for participants now, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
Contact Camila Dietrich (+55 51 9723-2844, camila.dietrich@hsl.org.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antimicrobial utilization at the ICU level (time frame: 14 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07093450, which also lists 1 linked publication.
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 3 Dec 2025.