Ventilator-Associated PneumoniaNCT05589727

Application of Ventilator-Associated Events (VAE) in Ventilator-Associated Pneumonia (VAP) Notified in Brazil

An observational study of Ventilator-Associated Pneumonia and Healthcare-Associated Pneumonia, run by Giovanna Marssola Nascimento at 12 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Multicentric observational prospective cohort study in 12 (twelve) hospitals representing all Brazilian regions. The main objective of this project is to evaluate the incidence of Ventilator-Associated Pneumonia (VAP) when using the current ANVISA criteria for VAP versus VAE criteria defined by the National Healthcare… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Ventilator-Associated Pneumonia, Healthcare-Associated Pneumonia, Healthcare Associated Infection
How many people: 987 participants
Where: 12 sitesBrazil
Study dates: 21 Oct 2022to 21 Jan 2024
Phase: Observational
Are there results?: None posted in the registry

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

Study population: All patients aged 18 years or older who are hospitalized in intensive care units (ICUs) using mechanical ventilation.

Who may be able to join

Patients aged 18 years or older
Pacients hospitalized in intensive care units (ICUs) using mechanical ventilation

Who cannot join

Patients withdrawn from mechanical ventilation (MV) on the first day (D1) or second day (D2), with D1 being the day of initiation of MV;
Patients with hospital discharge (discharge, death or transfer) on D1 or D2 of mechanical ventilation

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

Brazil12 sites

Hospital São Vicente de Paula
Barbalha, Ceará
Hospital Jean Bittar
Belém, Pará
Hospital Universitário de Brasília
Brasília, Federal District
Hospital Geral de Caxias do Sul
Caxias do Sul, Rio Do Grande Do Sul
Hospital OTOclínica
Fortaleza, Ceará
Hospital Geral de Goiânia Alberto Rassi
Goiânia, Goiás
Hospital Municipal de Maringá
Maringá, Paraná
Hospital do Tricentenário
Olinda, Pernambuco
Hospital Ernesto Dornelles
Porto Alegre, Rio Grande do Sul
Instituto Estadual do Cérebro Paulo Niemeyer
Rio de Janeiro, Rio de Janeiro
Hospital Presidente Vargas
São Luís, Maranhão
A. C. Camargo Cancer Center
São Paulo, São Paulo

Other trials in Brazil

About this study

Official title: Study to Validate the Application of the Epidemiological Diagnostic Criteria of Ventilator-Associated Events (VAE) in Ventilator-Associated Pneumonia (VAP) Notified to the Brazilian Health Regulatory Agency (ANVISA)

Multicentric observational prospective cohort study in 12 (twelve) hospitals representing all Brazilian regions.

The main objective of this project is to evaluate the incidence of Ventilator-Associated Pneumonia (VAP) when using the current ANVISA criteria for VAP versus VAE criteria defined by the National Healthcare Safety Network (NHSN). The diagnostic accuracy of the two criteria for identifying VAP will also be compared, characterizing other events associated with mechanical ventilation that are not VAP, when applicable.

The study also aims to adjudicate ventilator-associated pneumonias reported to ANVISA using current epidemiological diagnostic criteria.

Read the detailed description

The study will be carried out in about 12 centers, comprising the five Brazilian regions. It will be conducted from 2022 to 2024. Data collection will be performed at each center during six months.

Trained health professionals from Infections Control Committees of each participating center will collect data.

Mechanical ventilation data will be entered daily in the database system from the moment the patient is submitted to mechanical ventilation until the first day after the end of mechanical ventilation.

VAPs notified to ANVISA, according to its own criteria, will be reported monthly in the database system for adjudication.

The VAE definition will be performed automatically in the database system by mans of a specific algorithm. The diagnosis established by the system will be manually validated by a nurse with experience in healthcare-associated infection (HAI) surveillance. Agreement variables (Kappa) between the two criteria will be analyzed.

The adjudication will be carried out by two independent professionals (doctor and nurse) with experience in HAIs surveillance. In case of disagreement, there will be an evaluation by a third adjudicator.

The complete project was submitted to the local Institutional Review Board (IRB)/National Research Ethics Commission (CONEP) system and has ethical approval (CAAE: 52354721.0.1001.0070).

Conditions: Ventilator-Associated Pneumonia, Healthcare-Associated Pneumonia, Healthcare Associated Infection
Keywords: pneumonia, surveillance, healthcare associated infections, Ventilator-Associated Pneumonia, Healthcare-Associated Pneumonia
Medical subject headings: Pneumonia, Ventilator-Associated, Healthcare-Associated Pneumonia, Cross Infection, Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05589727
Study group	Role	What they receive
Patients with VAP - ANVISA criteria		Patients notified with Ventilator-Associated Pneumonia (VAP) when using the current ANVISA criteria.
Patients with VAP - NHSN criteria		Patients notified with Ventilator-Associated Pneumonia (VAP) when using the Ventilator-Associated Events (VAE) criteria defined by the NHSN.

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Ventilator-Associated Pneumonia (VAP) using two different surveillance criteria.
To evaluate the incidence of Ventilator-Associated Pneumonia (VAP) when using the current ANVISA criteria for VAP versus the criteria for events Ventilator-Associated Events (VAE) defined by the NHSN.
Measured: through study completion, an average of 6 months

Secondary outcomes (2)

Accuracy of the two criteria for identifying VAP
The diagnostic accuracy of the two criteria for identifying VAP will also be compared, characterizing other events associated with mechanical ventilation other than VAP, when applicable - Ventilator-Associated Condition (VAC), Infection-related Ventilator-Associated Complication (IVAC), Possible Ventilator-Associated Pneumonia (PVAP).
Measured: through study completion, an average of 6 months
Adjudication of VAP
To adjudicate ventilator-associated pneumonias reported to ANVISA using current epidemiological diagnostic criteria.
Measured: through study completion, an average of 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Oct 202221 Jan 2024

First posted21 Oct 2022
Study start21 Oct 2022
Primary completion21 Dec 2023
Study completion21 Jan 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Ventilator-Associated PneumoniaStudies 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 987 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05589727
Sponsor's protocol ID: IMPACTO MR-PAV
Status last verified: Nov 2024
First submitted: 13 Oct 2022
Last updated: 20 Nov 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Horan TC, Andrus M, Dudeck MA. CDC/NHSN surveillance definition of health care-associated infection and criteria for specific types of infections in the acute care setting. Am J Infect Control. 2008 Jun;36(5):309-32. doi: 10.1016/j.ajic.2008.03.002. No abstract available.
PubMed 18538699
Klompas M. Ventilator-Associated Events: What They Are and What They Are Not. Respir Care. 2019 Aug;64(8):953-961. doi: 10.4187/respcare.07059.
PubMed 31346070
Klompas M. The paradox of ventilator-associated pneumonia prevention measures. Crit Care. 2009;13(5):315. doi: 10.1186/cc8036. Epub 2009 Oct 15.
PubMed 19849825
Fan Y, Gao F, Wu Y, Zhang J, Zhu M, Xiong L. Does ventilator-associated event surveillance detect ventilator-associated pneumonia in intensive care units? A systematic review and meta-analysis. Crit Care. 2016 Oct 24;20(1):338. doi: 10.1186/s13054-016-1506-z.
PubMed 27772529
Raoof S, Baumann MH; Critical Care Societies Collaborative, consisting of the leadership of the American Association of Critical-Care Nurses, the American College of Chest Physicians, the American Thoracic Society, and the Society of Critical Care Medicine. Ventilator-associated events: the new definition. Am J Crit Care. 2014 Jan;23(1):7-9. doi: 10.4037/ajcc2014469. No abstract available.
PubMed 24382609
Stevens JP, Silva G, Gillis J, Novack V, Talmor D, Klompas M, Howell MD. Automated surveillance for ventilator-associated events. Chest. 2014 Dec;146(6):1612-1618. doi: 10.1378/chest.13-2255.
PubMed 25451350
Hebert C, Flaherty J, Smyer J, Ding J, Mangino JE. Development and validation of an automated ventilator-associated event electronic surveillance system: A report of a successful implementation. Am J Infect Control. 2018 Mar;46(3):316-321. doi: 10.1016/j.ajic.2017.09.006. Epub 2017 Nov 10.
PubMed 29132696
Sim J, Wright CC. The kappa statistic in reliability studies: use, interpretation, and sample size requirements. Phys Ther. 2005 Mar;85(3):257-68.
PubMed 15733050
Donner A, Eliasziw M. A goodness-of-fit approach to inference procedures for the kappa statistic: confidence interval construction, significance-testing and sample size estimation. Stat Med. 1992 Aug;11(11):1511-9. doi: 10.1002/sim.4780111109.
PubMed 1410963
Nascimento GM, Rodrigues DLG, Piastrelli FT, Cheno MY, Braz KCC, Alves LBO, Tomazini BM, Veiga VC, Arns B, Besen BAMP, Junior APN, Avezum A, da Silva RKL, de Azevedo CMPES, Silva MLSO, Kist GR, Salgado FB, de Moura MTF, Boschi E, Kurtz PMP, Miraglia ERVDS, de Lima TA, Pereira RR, Arraes JA, Alves de Oliveira Junior H. Ventilator-associated events criteria in the assessment of Ventilator-Associated Pneumonia (IMPACTO MR-PAV): A prospective cohort. Braz J Infect Dis. 2025 Jul-Aug;29(4):104543. doi: 10.1016/j.bjid.2025.104543. Epub 2025 May 22.
PubMed 40409133
Nascimento GM, Gomes Rodrigues DL, Mangas Catarino DG, Piastrelli FT, Cheno MY, Braz KCC, Oliveira Alves LB, Avezum A, Veiga VC, Zavascki AP, Tomazini B, Besen B, Pereira AJ, Marques de Pinho APN, De Oliveira Junior HA. Application of ventilator-associated events (VAE) in ventilator-associated pneumonia (VAP) notified in Brazil (IMPACTO MR-PAV): a protocol for a cohort study. BMJ Open. 2023 Dec 9;13(12):e076047. doi: 10.1136/bmjopen-2023-076047.
PubMed 38070904

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS
VAP - Ventilator Associated Pneumonia
RecruitingPhase 4
EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics
Blood Stream Infections, Ventilator Associated Pneumonia
Not yet recruiting
Mobile-Based Microlearning for Improving ICU Nurses' Adherence to Ventilator-Associated Pneumonia Prevention Protocols
Ventilator-Associated Pneumonia
Not yet recruitingPhase 3
Cefepime-Zidebactam Versus Ceftazidime-Avibactam With or Without Colistin for Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia
Hospital Acquired Bacterial Pneumonia (HABP), Ventilator Associated Bacterial Pneumonia (VABP)

All Ventilator-Associated Pneumonia trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study to Validate the Application of the Epidemiological Diagnostic Criteria of Ventilator-Associated Events (VAE) in Ventilator-Associated Pneumonia (VAP) Notified to the Brazilian Health Regulatory Agency (ANVISA)
ClinicalTrials.gov ID: NCT05589727
Acronym / sponsor ID: IMPACTO MR-PAV
Conditions: Ventilator-Associated Pneumonia, Healthcare-Associated Pneumonia, Healthcare Associated Infection
Keywords: pneumonia, surveillance, healthcare associated infections, Ventilator-Associated Pneumonia, Healthcare-Associated Pneumonia
Study type: Observational
Recruitment status: Completed
Enrolment: 987 participants (actual)
Lead sponsor: Giovanna Marssola NascimentoUniversity, hospital or other
Collaborators: Ministry of Health, Brazil
Study start: 21 Oct 2022 (actual)
Primary completion: 21 Dec 2023 (actual)
Study completion: 21 Jan 2024 (actual)
First posted: 21 Oct 2022 (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.

Multicentric observational prospective cohort study in 12 (twelve) hospitals representing all Brazilian regions.

The study also aims to adjudicate ventilator-associated pneumonias reported to ANVISA using current epidemiological diagnostic criteria.

Detailed description

The study will be carried out in about 12 centers, comprising the five Brazilian regions. It will be conducted from 2022 to 2024. Data collection will be performed at each center during six months.

Trained health professionals from Infections Control Committees of each participating center will collect data.

VAPs notified to ANVISA, according to its own criteria, will be reported monthly in the database system for adjudication.

The complete project was submitted to the local Institutional Review Board (IRB)/National Research Ethics Commission (CONEP) system and has ethical approval (CAAE: 52354721.0.1001.0070).

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Patients with VAP - ANVISA criteria	–	–Patients notified with Ventilator-Associated Pneumonia (VAP) when using the current ANVISA criteria.
Patients with VAP - NHSN criteria	–	–Patients notified with Ventilator-Associated Pneumonia (VAP) when using the Ventilator-Associated Events (VAE) criteria defined by the NHSN.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: All patients aged 18 years or older who are hospitalized in intensive care units (ICUs) using mechanical ventilation.

Key inclusion criteria (2 listed)

Patients aged 18 years or older
Pacients hospitalized in intensive care units (ICUs) using mechanical ventilation

Key exclusion criteria (2 listed)

Patients withdrawn from mechanical ventilation (MV) on the first day (D1) or second day (D2), with D1 being the day of initiation of MV;
Patients with hospital discharge (discharge, death or transfer) on D1 or D2 of mechanical ventilation

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Incidence of Ventilator-Associated Pneumonia (VAP) using two different surveillance criteria.
Time frame: through study completion, an average of 6 months
To evaluate the incidence of Ventilator-Associated Pneumonia (VAP) when using the current ANVISA criteria for VAP versus the criteria for events Ventilator-Associated Events (VAE) defined by the NHSN.

2 secondary outcomes

Accuracy of the two criteria for identifying VAP
Time frame: through study completion, an average of 6 months
Adjudication of VAP
Time frame: through study completion, an average of 6 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
Background: PubMed 18538699Horan TC, Andrus M, Dudeck MA. CDC/NHSN surveillance definition of health care-associated infection and criteria for specific types of infections in the acute care setting. Am J Infect Control. 2008 Jun;36(5):309-32. doi: 10.1016/j.ajic.2008.03.002. No abstract available.
Background: PubMed 31346070Klompas M. Ventilator-Associated Events: What They Are and What They Are Not. Respir Care. 2019 Aug;64(8):953-961. doi: 10.4187/respcare.07059.
Background: PubMed 19849825Klompas M. The paradox of ventilator-associated pneumonia prevention measures. Crit Care. 2009;13(5):315. doi: 10.1186/cc8036. Epub 2009 Oct 15.
Background: PubMed 27772529Fan Y, Gao F, Wu Y, Zhang J, Zhu M, Xiong L. Does ventilator-associated event surveillance detect ventilator-associated pneumonia in intensive care units? A systematic review and meta-analysis. Crit Care. 2016 Oct 24;20(1):338. doi: 10.1186/s13054-016-1506-z.
Background: PubMed 24382609Raoof S, Baumann MH; Critical Care Societies Collaborative, consisting of the leadership of the American Association of Critical-Care Nurses, the American College of Chest Physicians, the American Thoracic Society, and the Society of Critical Care Medicine. Ventilator-associated events: the new definition. Am J Crit Care. 2014 Jan;23(1):7-9. doi: 10.4037/ajcc2014469. No abstract available.
Background: PubMed 25451350Stevens JP, Silva G, Gillis J, Novack V, Talmor D, Klompas M, Howell MD. Automated surveillance for ventilator-associated events. Chest. 2014 Dec;146(6):1612-1618. doi: 10.1378/chest.13-2255.
Background: PubMed 29132696Hebert C, Flaherty J, Smyer J, Ding J, Mangino JE. Development and validation of an automated ventilator-associated event electronic surveillance system: A report of a successful implementation. Am J Infect Control. 2018 Mar;46(3):316-321. doi: 10.1016/j.ajic.2017.09.006. Epub 2017 Nov 10.
Background: PubMed 15733050Sim J, Wright CC. The kappa statistic in reliability studies: use, interpretation, and sample size requirements. Phys Ther. 2005 Mar;85(3):257-68.
Background: PubMed 1410963Donner A, Eliasziw M. A goodness-of-fit approach to inference procedures for the kappa statistic: confidence interval construction, significance-testing and sample size estimation. Stat Med. 1992 Aug;11(11):1511-9. doi: 10.1002/sim.4780111109.
Derived from this study: PubMed 40409133Nascimento GM, Rodrigues DLG, Piastrelli FT, Cheno MY, Braz KCC, Alves LBO, Tomazini BM, Veiga VC, Arns B, Besen BAMP, Junior APN, Avezum A, da Silva RKL, de Azevedo CMPES, Silva MLSO, Kist GR, Salgado FB, de Moura MTF, Boschi E, Kurtz PMP, Miraglia ERVDS, de Lima TA, Pereira RR, Arraes JA, Alves de Oliveira Junior H. Ventilator-associated events criteria in the assessment of Ventilator-Associated Pneumonia (IMPACTO MR-PAV): A prospective cohort. Braz J Infect Dis. 2025 Jul-Aug;29(4):104543. doi: 10.1016/j.bjid.2025.104543. Epub 2025 May 22.
Derived from this study: PubMed 38070904Nascimento GM, Gomes Rodrigues DL, Mangas Catarino DG, Piastrelli FT, Cheno MY, Braz KCC, Oliveira Alves LB, Avezum A, Veiga VC, Zavascki AP, Tomazini B, Besen B, Pereira AJ, Marques de Pinho APN, De Oliveira Junior HA. Application of ventilator-associated events (VAE) in ventilator-associated pneumonia (VAP) notified in Brazil (IMPACTO MR-PAV): a protocol for a cohort study. BMJ Open. 2023 Dec 9;13(12):e076047. doi: 10.1136/bmjopen-2023-076047.
ANVISA - Nota Tecnica GVIMS/GGTES/DIRE3/ANVISA nº 03/2024 - Critérios diagnósticos de IRASLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Ventilator-Associated Pneumonia

Not yet recruitingObservational study
Traditional Chinese Medicine in Multidrug-Resistant Bacterial Pneumonia
Multi Drug Resistant Infections, Pneumnia
Not yet recruitingObservational study
Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS
VAP - Ventilator Associated Pneumonia
RecruitingPhase 4
EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics
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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.

Giovanna M Nascimento, MD principal investigator

Hospital Alemão Oswaldo Cruz

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Ventilator-Associated Pneumonia and Healthcare-Associated Pneumonia, run by Giovanna Marssola Nascimento at 12 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?

The sponsor lists 2 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: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Incidence of Ventilator-Associated Pneumonia (VAP) using two different surveillance criteria. (time frame: through study completion, an average of 6 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 NCT05589727, which also lists 11 linked publications.

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 20 Nov 2024.