Идёт набор NCT07086391

Different Methods of Aerosolized Polymyxin B Inhalation for Treating Carbapenem-Resistant Gram-Negative Bacterial Pneumonia.

— Наблюдательное Carbapenem-Resistant Enterobacteriaceae Infection Pneumonia - Bacterial

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: Polymyxin B Sulfate 25mg Jet Nebulization / Vibrating Mesh Nebulization.
Кому может быть актуально: Состояния в реестре: Carbapenem-Resistant Enterobacteriaceae Infection, Pneumonia - Bacterial. Базовые параметры: 18 лет — 90 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: Китай
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

A Prospective Clinical Study on Different Methods of Aerosolized Polymyxin B Inhalation for the Treatment of Carbapenem-Resistant Gram-Negative Bacterial Pneumonia

Обзор

Study Design: A randomized, open-label, parallel-group clinical trial comparing the efficacy and safety of jet nebulization versus vibrating mesh nebulization of sulfate polymyxin B in mechanically ventilated patients with carbapenem-resistant Gram-negative bacterial pneumonia. Participants: 144 patients (72 per group) will be enrolled from December 2023 to December 2025. Interventions: Group A: 25mg polymyxin B + 5ml sterile water via jet nebulizer (respirator-assisted). Group B: 25mg polymyxin B + 5ml sterile water via vibrating mesh nebulizer (respirator-assisted). Both groups receive additional intravenous polymyxin B (2.0mg/kg loading dose, followed by 1.25mg/kg every 12h) starting 12h after nebulization. Treatment duration: 14 days. Key Procedures: Nebulization parameters: Fixed ventilator settings (SIMV+PSV mode, tidal volume 8ml/kg, PEEP 6cmH₂O). Bronchoalveolar lavage (BAL) and blood sampling: BAL fluid (BALF) and blood collected pre-nebulization (baseline), 1h post-nebulization, and at steady-state (days 3-7). BALF analyzed for polymyxin B concentration, urea nitrogen, and inflammatory mediators (IL-6, TNF-α, etc.). Primary Outcomes: Clinical efficacy: Total response rate (cure + improvement). 28-day survival rate. Time to fever resolution and bacterial clearance. Drug exposure: Polymyxin B concentration in alveolar epithelial lining fluid (ELF) and blood. Secondary Outcomes: Inflammatory response: Changes in BALF and serum IL-6, TNF-α, CRP levels. Safety: Nephrotoxicity (changes in serum creatinine/urea nitrogen). Airway complications (bronchospasm incidence). Assessment Timeline: Clinical monitoring: Daily evaluation of vital signs, sputum volume, and ventilator parameters. Lab tests: Blood tests (hematology, renal function, inflammatory markers) at baseline, days 3/7/14. Microbiological evaluation: Sputum cultures on days 3/7/14. Statistical Analysis: Efficacy and safety endpoints compared between groups using t-tests or chi-square tests. A p-value \<0.05 will be considered statistically significant.

Вмешательства

Устройство Polymyxin B Sulfate 25mg Jet Nebulization / Vibrating Mesh Nebulization
* Group A: 25mg polymyxin B sulfate dissolved in 5ml sterile water, administered via jet nebulizer under mechanical ventilation. * Group B: 25mg polymyxin B sulfate dissolved in 5ml sterile water, administered via vibrating mesh nebulizer under mechanical ventilation.

Первичные конечные точки

Clinical efficacy [Срок оценки: Baseline (pre-treatment); End of Treatment (EOT, 14 days after starting polymyxin B)]

Вторичные конечные точки (2)

28-Day Survival Rate [Срок оценки: Baseline (pre-treatment); End of Treatment (EOT, 28 days after starting polymyxin B)]
Microbiological Clearance Rate [Срок оценки: Baseline (pre-treatment); End of Treatment (EOT, 14 days after starting polymyxin B)]

Критерии участия

Критерии включения

Pneumonia diagnosed per Chinese Thoracic Society criteria (radiographic + clinical evidence).
Sputum culture-confirmed carbapenem-resistant Gram-negative bacteria susceptible to polymyxin B.
≥3 days of aerosolized polymyxin B therapy.
Mechanically ventilated with an artificial airway.