Ventilator Associated TracheobronchitisVATICANNCT05266066
Ventilator-associated Tracheobronchitis Initiative to Conduct Antibiotic Evaluation
A study testing Clinical observation without antibiotic therapy for VAT and 7 day antibiotic course for VAT in people with Ventilator Associated Tracheobronchitis and Tracheobronchitis, run by Hospital Sirio-Libanes at 16 sites in Brazil.
Trial summary
The Ventilator Associated tracheobronchitis Initiative to Conduct Antibiotic evaluation (VATICAN) trial is a national, multicenter, non-inferiority trial in ICU patients comparing antibiotic treatment for 7 days versus clinical observation without antibiotic treatment for patients with ventilator-associated… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Associated Tracheobronchitis, Tracheobronchitis
- What is being tested?
- Clinical observation without antibiotic therapy for VAT and 7 day antibiotic course for VAT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 590 participants
- Where
- 16 sitesBrazil
- Study dates
- 11 Jul 2022to 1 Dec 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
Who may be able to join
- Admission to one of the participating ICUs
- Invasive Mechanical ventilation ≥ 48 hours
- Available chest imaging of screening day
- Clinical diagnosis of VAT, defined by the presence of:
- Temperature >38.0°C or <36°C OR leukocytes >12000/mL or <4000/mL or presence >10% of immature forms, AND
- Onset of purulent tracheal secretion, or change in characteristics of the secretion, or increase in the amount of respiratory secretion, or increased need for aspiration
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- Culture of tracheal secretion from the day of screening under analysis or collected for analysis
- Expected limitation of care or early withdrawal of supportive therapies (< 7 days)
- Patients with a survival expectancy of less than 48 hours
- Refusal of consent to participate in the study
Who cannot join
- Pregnant or lactating women
- Indication of use of antibiotics or use of systemic antibiotics for any indications at the time of screening
- Hemodynamic instability, defined as hypotension unresponsive to volume expansion or increase in vasopressor dose > 0.1mcg/kg/min of noradrenaline or equivalent in the past 6 hours
- Worsening of gas exchange, defined as an increase in the fraction of inspired oxygen ≥ 20% or an increase in positive end-expiratory pressure (PEEP) ≥ 3 cm of water after a stability period ≥ 2 days
- Prolonged mechanical ventilation, defined by use of invasive mechanical ventilation for 21 days or more
- Presence of pulmonary radiological image suggestive of new infectious infiltrate
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- Previous lung disease that makes radiological interpretation for the diagnosis of VAP difficult
- Previous diagnosis of ventilator associates pneumonia (VAP) during hospitalization
- Neutropenic patients (neutrophils <1000/mL)
- Known severe immunosuppression
- Tracheostomized patients at the time of screening
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Brazil16 sites
Hospital Santa Casa de Belo Horizonte
Belo Horizonte, Minas Gerais
Hospital OTOClinica
Fortaleza, Ceará
Hospital Itapetininga
Itapetininga, São Paulo
Hospital Unimed Limeira
Limeira, São Paulo
Hospital Universitário Regional do Norte do Paraná
Londrina, Paraná
Hospital Municipal de Maringá
Maringá, Paraná
Hospital Vila da Serra
Nova Lima, Minas Gerais
Hospital Tricentenário
Olinda, Pernambuco
Santa Casa de Misericórdia de Passos
Passos, Minas Gerais
Hospital Ernesto Dornelles
Porto Alegre, Rio Grande do Sul
Hospital Estadual Mario Covas
Santo André, São Paulo
Hospital São Joao Del Rei
São João del Rei, Minas Gerais
Hospital Samaritano
São Paulo, São Paulo
Hospital São Paulo
São Paulo, São Paulo
Hospital Santa Casa de Sorocaba
Sorocaba, São Paulo
Hospital Vila Velha
Vila Velha, Espírito Santo
About this study
Official title: Multicenter Randomized Clinical Trial of Antimicrobial Treatment in Ventilator-associated Tracheobronchitis
The Ventilator Associated tracheobronchitis Initiative to Conduct Antibiotic evaluation (VATICAN) trial is a national, multicenter, non-inferiority trial in ICU patients comparing antibiotic treatment for 7 days versus clinical observation without antibiotic treatment for patients with ventilator-associated tracheobronchitis.
Read the detailed description
There is no consensus on the need for antibiotic treatment for ventilator-associated tracheobronchitis (VAT). There's a lack of high-quality clinical data on this subject, and although some observational studies recommend antibiotic treatment for VAT, some guidelines do not. The VATICAN is a prospective, randomized, single-blinded (analysis), non-inferiority trial evaluating antibiotic treatment for patients with ventilator-associated tracheobronchitis. Patients with clinically diagnosed tracheobronchitis will be randomized to receive antibiotics for 7 days versus clinical observation without antibiotic treatment for VAT. The primary hypothesis is that clinical observation without antibiotic treatment is noninferior to 7-day antibiotic course.
- Being tested
- Clinical observation without antibiotic therapy for VAT, 7 day antibiotic course for VAT
- Keywords
- Antibiotics, Ventilator associated Tracheobronchitis, Mechanical ventilation, Critically ill
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical observation without antibiotic therapy for VATOther
Patients will receive standard care plus antibiotic if new organ dysfunction or new infections other than VAT.
7 day antibiotic course for VATOther
Patients will receive standard care plus 7 day course of antibiotic.
| Study group | Role | What they receive |
|---|---|---|
| Clinical observation without antibiotic therapy for VAT | Experimental | Patients will receive standard care and no antibiotic therapy for VAT. Antibiotics will be prescribed if other infections and/or organ dysfunction ensues (especially shock) or there is progression to pneumonia Receives: Other: Clinical observation without antibiotic therapy for VAT |
| 7 day antibiotic course for VAT | Active comparator | Patients will receive standard care and 7 day course of antibiotic therapy for VAT. Receives: Other: 7 day antibiotic course for VAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator free days
Days alive and free from mechanical ventilation
Measured: 28 days after randomization
Secondary outcomes (8)
Ventilator associated pneumonia-free survival (Key secondary outcome)
The time between randomization and the diagnostic event of ventilator associated pneumonia or death
Measured: 28 days after randomization
Mortality
All cause mortality
Measured: 28 days after randomization
Ventilator associated pneumonia
Ventilator associated pneumonia incidence
Measured: 14 and 28 days after randomization
Intensive care unit free days
Days alive and free from intensive care unit
Measured: 28 days after randomization
Organ dysfunction
Variation in organ dysfunction (measured by the Sequential Organ Failure Assessment Score). Sequential Organ Failure Assessment scores are measured in 6 organ systems (cardiovascular, hematologic, gastrointestinal, renal, pulmonary and neurologic), with each organ scored from 0 to 4, resulting in an aggregated score that ranges from 0 to 24, with higher scores indicating greater dysfunction.
Measured: Between randomization and day 7.
Microbiological isolation of multi-resistant bacteria
Microbiological isolation of multi-resistant bacteria. Any isolation of by microbiological cultures of multi-resistant bacteria following the definition:
Acinetobacter baumannii: Resistant to carbapenems and/or polymyxins Pseudomonas aeruginosa: Resistant to carbapenems and/or polymyxins Enterobacteriaceae: Resistant to carbapenems and/or polymyxins (in enterobacteria naturally sensitive to polymyxins) Vancomycin-resistant Enterococcus faecium (VRE) Methicillin/Oxacillin Resistant Staphylococcus aureus (MRSA) Methicillin/Oxacillin-Resistant Coagulase Negative Staphylococcus (MRSA)
Measured: 28 days after randomization
Antibiotic free days
Days alive and free from antibiotic
Measured: 28 days after randomization
Cost analysis
Cost effectiveness analysis. Direct and indirect hospital costs will be measured and used in the analyses. For that, a local costing system will be built, using the absorption costing methodology (top-down).
Measured: For the first 28 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start11 Jul 2022
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ventilator Associated TracheobronchitisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized 1:1 to Clinical observation without antibiotic therapy for VAT vs. 7 day antibiotic course.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 590 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Sirio-Libanes
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Israelita Albert Einstein, Hospital do Coracao, Hospital Moinhos de Vento, Hospital Alemão Oswaldo Cruz, Beneficência Portuguesa de São Paulo, Brazilian Research In Intensive Care Network
- Responsible party
- Sponsor
- Investigators
- Bruno M Tomazini, MD, Principal investigator, Hospital Sirio-Libanes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05266066
- Sponsor's protocol ID
- 48749421.0.1001.5461
- Acronym
- VATICAN
- Status last verified
- Jul 2026
- First submitted
- 15 Feb 2022
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 committee after the study completion.
Publications
IMPACTO-MR, VATICAN Trial Investigators and BRICNet; Tomazini BM, Besen BAMP, Dietrich C, Gandara APR, Silva DP, Pinheiro CCG, Luz MN, Mattos RR, Reis LFL, Roepke RML, Duarte CSLG, Nassar Junior AP, Veiga VC, Arns B, Nascimento GM, Pereira AJ, Cavalcanti AB, Machado FR, Azevedo LCP. VATICAN (Ventilator-Associated Tracheobronchitis Initiative to Conduct Antibiotic Evaluation): protocol for a multicenter randomized open-label trial of watchful waiting versus antimicrobial therapy for ventilator-associated tracheobronchitis. Crit Care Sci. 2024 Aug 26;36:e20240029en. doi: 10.62675/2965-2774.20240029-en. eCollection 2024.
PubMed 39194024Tomazini 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 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Clinical Trial of Antimicrobial Treatment in Ventilator-associated Tracheobronchitis
- ClinicalTrials.gov ID
- NCT05266066
- Acronym / sponsor ID
- VATICAN / 48749421.0.1001.5461
- Keywords
- Antibiotics, Ventilator associated Tracheobronchitis, Mechanical ventilation, Critically ill
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 590 participants (estimated)
- Lead sponsor
- Hospital Sirio-LibanesUniversity, hospital or other
- Collaborators
- Hospital Israelita Albert Einstein, Hospital do Coracao, Hospital Moinhos de Vento, Hospital Alemão Oswaldo Cruz, Beneficência Portuguesa de São Paulo, Brazilian Research In Intensive Care Network
- Study start
- 11 Jul 2022 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 4 Mar 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.
The Ventilator Associated tracheobronchitis Initiative to Conduct Antibiotic evaluation (VATICAN) trial is a national, multicenter, non-inferiority trial in ICU patients comparing antibiotic treatment for 7 days versus clinical observation without antibiotic treatment for patients with ventilator-associated tracheobronchitis.
Detailed description
There is no consensus on the need for antibiotic treatment for ventilator-associated tracheobronchitis (VAT). There's a lack of high-quality clinical data on this subject, and although some observational studies recommend antibiotic treatment for VAT, some guidelines do not. The VATICAN is a prospective, randomized, single-blinded (analysis), non-inferiority trial evaluating antibiotic treatment for patients with ventilator-associated tracheobronchitis. Patients with clinically diagnosed tracheobronchitis will be randomized to receive antibiotics for 7 days versus clinical observation without antibiotic treatment for VAT. The primary hypothesis is that clinical observation without antibiotic treatment is noninferior to 7-day antibiotic course.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomized 1:1 to Clinical observation without antibiotic therapy for VAT vs. 7 day antibiotic course.
| Arm | Type | Receives |
|---|---|---|
| Clinical observation without antibiotic therapy for VAT | Experimental | Other: Clinical observation without antibiotic therapy for VATPatients will receive standard care and no antibiotic therapy for VAT. Antibiotics will be prescribed if other infections and/or organ dysfunction ensues (especially shock) or there is progression to pneumonia |
| 7 day antibiotic course for VAT | Active comparator | Other: 7 day antibiotic course for VATPatients will receive standard care and 7 day course of antibiotic therapy for VAT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Admission to one of the participating ICUs
- Invasive Mechanical ventilation ≥ 48 hours
- Available chest imaging of screening day
- Clinical diagnosis of VAT, defined by the presence of:
- Culture of tracheal secretion from the day of screening under analysis or collected for analysis
Key exclusion criteria (11 listed)
- Pregnant or lactating women
- Indication of use of antibiotics or use of systemic antibiotics for any indications at the time of screening
- Hemodynamic instability, defined as hypotension unresponsive to volume expansion or increase in vasopressor dose > 0.1mcg/kg/min of noradrenaline or equivalent in the past 6 hours
- Worsening of gas exchange, defined as an increase in the fraction of inspired oxygen ≥ 20% or an increase in positive end-expiratory pressure (PEEP) ≥ 3 cm of water after a stability period ≥ 2 days
- Prolonged mechanical ventilation, defined by use of invasive mechanical ventilation for 21 days or more
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 |
|---|---|---|
| Clinical observation without antibiotic therapy for VATPatients will receive standard care plus antibiotic if new organ dysfunction or new infections other than VAT. | Other | Clinical observation without antibiotic therapy for VAT |
| 7 day antibiotic course for VATPatients will receive standard care plus 7 day course of antibiotic. | Other | 7 day antibiotic course for VAT |
Primary outcome
Ventilator free days
Time frame: 28 days after randomization
Days alive and free from mechanical ventilation
8 secondary outcomes
Ventilator associated pneumonia-free survival (Key secondary outcome)
Time frame: 28 days after randomization
Mortality
Time frame: 28 days after randomization
Ventilator associated pneumonia
Time frame: 14 and 28 days after randomization
Intensive care unit free days
Time frame: 28 days after randomization
Organ dysfunction
Time frame: Between randomization and day 7.
Microbiological isolation of multi-resistant bacteria
Time frame: 28 days after randomization
Antibiotic free days
Time frame: 28 days after randomization
Cost analysis
Time frame: For the first 28 days after randomization
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 27 Jul 2026.
- Results publication: PubMed 39194024IMPACTO-MR, VATICAN Trial Investigators and BRICNet; Tomazini BM, Besen BAMP, Dietrich C, Gandara APR, Silva DP, Pinheiro CCG, Luz MN, Mattos RR, Reis LFL, Roepke RML, Duarte CSLG, Nassar Junior AP, Veiga VC, Arns B, Nascimento GM, Pereira AJ, Cavalcanti AB, Machado FR, Azevedo LCP. VATICAN (Ventilator-Associated Tracheobronchitis Initiative to Conduct Antibiotic Evaluation): protocol for a multicenter randomized open-label trial of watchful waiting versus antimicrobial therapy for ventilator-associated tracheobronchitis. Crit Care Sci. 2024 Aug 26;36:e20240029en. doi: 10.62675/2965-2774.20240029-en. eCollection 2024.
- 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 committee after the study completion.
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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.
Bruno M Tomazini, MD principal investigator
Hospital Sirio-Libanes
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical observation without antibiotic therapy for VAT and 7 day antibiotic course for VAT in people with Ventilator Associated Tracheobronchitis and Tracheobronchitis, run by Hospital Sirio-Libanes at 16 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 10 inclusion and 11 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 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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?
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?
Ventilator free days (time frame: 28 days after randomization). 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 NCT05266066, which also lists 2 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 27 Jul 2026.