Antibiotics or watchful waiting? a trial puts ventilator tracheobronchitis to the test
NCT ID NCT05266066
First seen Jul 27, 2026 · Last updated Jul 28, 2026 · Updated 1 time
Summary
This trial tests whether giving antibiotics for a week is better than simply monitoring patients who develop ventilator-associated tracheobronchitis, a lung airway infection common in ICU patients on breathing machines. Researchers will compare how many days patients are free from the ventilator and whether pneumonia or death occurs. The goal is to see if avoiding antibiotics is safe and effective.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- antibiotics (7-day course) versus clinical observation without antibiotics
- What this could lead to
- If observation alone proves non-inferior, it could reduce unnecessary antibiotic use in ICUs, lowering side effects and resistance.
- What could go wrong
- This is a non-inferiority trial, so it may not prove observation is better—only that it's not much worse. Risks include missing a hidden infection without antibiotics.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 590 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2022
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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: 1. Temperature \>38.0°C or \<36°C OR leukocytes \>12000/mL or \<4000/mL or presence \>10% of immature forms, AND 2. 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 * Culture of tracheal secretion from the day of screening under analysis or collected for analysis Exclusion Criteria: * 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 * 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 * Inclusion in the study in the past 30 days * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hospital Ernesto Dornelles
Porto Alegre, Rio Grande do Sul, Brazil
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Hospital Estadual Mario Covas
Santo André, São Paulo, Brazil
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Hospital Itapetininga
Itapetininga, São Paulo, Brazil
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Hospital Municipal de Maringá
Maringá, Paraná, Brazil
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Hospital OTOClinica
Fortaleza, Ceará, Brazil
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Hospital Samaritano
São Paulo, São Paulo, Brazil
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Hospital Santa Casa de Belo Horizonte
Belo Horizonte, Minas Gerais, Brazil
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Hospital Santa Casa de Sorocaba
Sorocaba, São Paulo, Brazil
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Hospital São Joao Del Rei
São João del Rei, Minas Gerais, Brazil
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Hospital São Paulo
São Paulo, São Paulo, Brazil
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Hospital Tricentenário
Olinda, Pernambuco, Brazil
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Hospital Unimed Limeira
Limeira, São Paulo, Brazil
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Hospital Universitário Regional do Norte do Paraná
Londrina, Paraná, Brazil
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Hospital Vila Velha
Vila Velha, Espírito Santo, Brazil
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Hospital Vila da Serra
Nova Lima, Minas Gerais, Brazil
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Santa Casa de Misericórdia de Passos
Passos, Minas Gerais, Brazil
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