Идёт набор NCT06743529

Immediate Versus Substantiated Antibiotic Therapy in Suspected Non-Severe Ventilator-Associated Pneumonia

Без фазы С лечением Ventilator-Associated Pneumonia (VAP)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: control group, Conservative strategy.
Кому может быть актуально: Состояния в реестре: Ventilator-Associated Pneumonia (VAP). Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция, Guadeloupe
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Immediate Versus Substantiated Antibiotic Therapy in Suspected Non-Severe Ventilator-Associated Pneumonia: A Randomized Controlled Trial

Обзор

Ventilator-associated pneumonia is the leading nosocomial infection in the intensive care units, and is associated with prolonged mechanical ventilation and overuse of antibiotics. Initiating antibiotic therapy immediately after bacteriological sampling (immediate strategy) may expose uninfected patients to unnecessary treatment, while waiting for bacteriological confirmation (conservative strategy) may delay ventilator-associated pneumonia in infected patients. The decision to start antibiotic therapy for ventilator-associated pneumonia takes three points into account: diagnostic probability, the risks to the patient if Antibiotic Therapy is delayed, and the risk of selection of resistant bacteria. Diagnostic probability is limited, given the subjective and non-specific nature of the diagnostic criteria, and only 30-50% of suspected cases are confirmed bacteriologically (whereas samples are only taken when the pre-test probability is sufficient). The risks associated with delayed antibiotic therapy are unknown, as few observational studies have directly assessed the impact of the timing of Antibiotic Therapy initiation on outcome (frequent confusion between delayed and inappropriate Antibiotic Therapy). Iregui et al. found that delaying Antibiotic Therapy by more than 24 hours was associated with higher mortality. However, more recent before-and-after studies have shown that the conservative strategy was associated with lower mortality, more frequently appropriate initial Antibiotic Therapy and shorter duration of Antibiotic Therapy. Similarly, in a recent before-and-after study by our team, initiating antibiotic therapy only upon microbiological confirmation of ventilator-associated pneumonia without septic shock or severe acute respiratory distress syndrome was not associated with an increase in ventilation time, length of stay or excess mortality at D28; but was associated with antibiotic therapy that was more often appropriate (DELAVAP, MARTIN et al, Annals of Intensive Care, 2024). Finally, the recent multicenter TARPP pilot study in surgical intensive care suggests that antibiotic therapy initiated on the basis of microbiological data in patients with suspected ventilator-associated pneumonia not requiring vasopressor support is not associated with a poorer outcome than immediate antibiotic therapy without documentation (the only randomized study on this subject). Antibiotic Therapy for suspected ventilator-associated pneumonia that is not subsequently confirmed is an unnecessary use of antibiotics and carries a risk of selection of resistant bacteria, with adverse effects on public health. It has been reported that a conservative Antibiotic Therapy prescription strategy for intensive care units -acquired infections reduces Antibiotic Therapy use and the incidence of acquired β-lactamase-producing Enterobacteriaceae infections. Overall, in patients with suspected ventilator-associated pneumonia but no signs of clinical severity, given the uncertainty about attributable mortality and concerns about bacterial resistance, the evaluation of the conservative Antibiotic Therapy strategy is reasonable. Some French intensive care units already delay Antibiotic Therapy until confirmation of ventilator-associated pneumonia, except in patients with severe hypoxemia or the need for vasopressor support.

Вмешательства

Процедура control group
immediate empiric Antibiotic Therapy (started within 1 hour after randomization) with antibiotic(s) chosen by the bedside physician based on time of ventilator-associated pneumoniaoccurrence, risk of antimicrobial resistance, local ecology, and local protocol. If the respiratory samples are negative, Antibiotic Therapy will be stopped. If ventilator-associated pneumonia is confirmed by positive samples, Antibiotic Therapy active against the recovered bacterial specie(s) will be given for a total
Процедура Conservative strategy
No Antibiotic Therapy until receipt of the respiratory sample culture and/or polymerase chain reaction results. If these results are negative, no Antibiotic Therapy is given. If they are positive (confirmed ventilator-associated pneumonia), Antibiotic Therapy is started as appropriate for the bacterial specie(s) detected by culture and/or polymerase chain reaction, without considering gram-stain results and without waiting for antimicrobial susceptibility testing results, and continued for a tot

Первичные конечные точки

Proportion of patients who die whithin 28 days or are still on invasive mechanical ventilation on day 28 [Срок оценки: From day 0 to day 28]

Вторичные конечные точки (12)

Sequential Organ Failure Assessment (SOFA) score [Срок оценки: From day 0 to day 7]
Modified clinical pulmonary infection score (mCPIS) [Срок оценки: From day 0 to day 7]
Clinical cure [Срок оценки: day 7]
Invasive mechanical ventilation duration [Срок оценки: From day 0 to day 28]
Ventilator free days [Срок оценки: From day 0 to day 28]
Use of vasopressors [Срок оценки: From day 0 to day 28]
Use of renal replacement therapy [Срок оценки: From day 0 to day 28]
Mortality rates [Срок оценки: ICU discharge, an average of 10 days]
Mortality rates [Срок оценки: day 28]
Mortality rates [Срок оценки: day 90]
Mortality rates [Срок оценки: Hospital discharge, an average of 20 days]
ICU stay lenghts [Срок оценки: From day 0 until the day of discharge from ICU, an average of 10 days]

Критерии участия

Критерии включения

Invasive mechanical ventilation for longer than 48 hours
Respiratory sample collection taken less than two hours ago (at physician discretion, according to local protocol) for a first episode of suspected ventilator-associated pneumonia (meeting the following prespecified criteria) :

new or changing chest X-ray infiltrates
plus at least two of the following:

body temperature ≥38.3°C or ≤35.5°C,
blood leukocyte count >12 000/µL or <4000/µL,
purulent tracheobronchial aspirate.
Age ≥18 years
Informed consent from the patient or next of kin to participation in the trial, or emergency procedure if no next of kin is available
Patients affiliated to a social security system

Non-inclusion Criteria:

Criteria for severe ventilator-associated pneumonia defined as:

Vasopressor therapy for onset of septic shock around the time of ventilator-associated pneumonia suspicion
Onset or severe worsening of hypoxemia (PaO2/FiO2<150 with 60% FiO2 and 10 mm H2O peak expiratory pressure, or patient on veno-venous extracorporeal membrane oxygenation)
Immunosuppression defined as :

leukocytes <1G/L or neutrophils <0,5 G/L
within the last 3 months
hematopoietic stem-cell transplant or organ transplant with chronic immunosuppressant therapy
HIV infection with CD4<50/mm3
chronic corticosteroid use (>0.5 mg/kg day for at least one month within the last three months).
Patient already on Antibiotic Therapy of predicted duration ≥4 weeks (endocarditis, spondylodiscitis, abscess...)
Previous ventilator-associated pneumonia suspicion with sampling and/or Antibiotic Therapy for suspected ventilator-associated pneumonia
Previous inclusion in the trial
Patient included in an interventional study on ventilator-associated pneumonia management with the same primary endpoint.
Pregnancy, recent delivery, or breastfeeding
Correctional facility inmate, adult under guardianship
Patient under legal protection
Life expectancy less than 48 h and/or decision not to treat potential pneumonia acquired under mechanical ventilation in the context of limiting/discontinuing treatment.
Organ donor reanimation

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет