A Randomized Sham-Controlled Trial of Bronchoscopic Levofloxacin and Gentamicin Versus Sham in Mechanically Ventilated Bronchiectasis: Acute and 1-Year Outcomes
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 315
- 试验地点
- 1
- 主要终点
- Days for weaning from mechanical ventilation
研究概览
简要总结
Randomized single-center trial evaluating whether bronchoscopic instillation of levofloxacin or gentamicin improves outcomes compared to a sham bronchoscopic procedure in adult ICU patients with non-cystic fibrosis bronchiectasis requiring invasive mechanical ventilation. The primary outcome is a ranked composite of in-hospital mortality and time to ventilator liberation. Safety and procedural adverse events are closely monitored.
详细描述
Bronchiectasis is a chronic suppurative and inflammatory lung disease of diverse etiology characterized by pathological and irreversible dilatation of the bronchial tree. The impairment of the mucociliary clearance, which results from chronic airway inflammation, may cause long-term colonization or recurrent infection of bacteria, especially Pseudomonas aeruginosa (PA), while bacterial colonization and recurrent infection can aggravate airway inflammation. Sputum retention caused by the impairment of mucociliary clearance can result in mucous plugs, which in turn contribute to airflow obstruction and dyspnea.
Clinically, the major manifestations of bronchiectasis include chronic cough with purulent sputum, dyspnea, and fatigue, which can significantly diminish patients' quality of life. The frequency of exacerbations and decline in lung function may lead to a poor prognosis and a decrease in quality of life.
The purpose of bronchiectasis management is to reduce exacerbations, prevent complications, and improve the quality of life. Long-term instillation of antibiotics and steroids can reduce the concentration of bacteria in the airways, decrease sputum production, attenuate lung function decline, and reduce acute pulmonary exacerbations without nephrotoxicity or ototoxicity. Dexamethasone is one of the most common glucocorticoids that can inhibit the expression levels of inflammatory factors in the airway and reduce the secretion of airway mucus. Topical administration could also reduce the systemic side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) All participants, clinical care providers (including bedside staff), investigators, and outcomes assessors will be blinded to group allocation. The use of a sham bronchoscopic procedure in the control arm ensures that all patients undergo a procedure of similar appearance and duration, minimizing the risk of performance and detection bias. Unblinding will only occur in the event of medically necessary interventions during the sham procedure, which will be documented as protocol deviations while maintaining the intention-to-treat analysis.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with bronchiectasis confirmed by high-resolution CT chest(HRCT)
- •patients with acute exacerbation of bronchiectasis who need antibiotic treatment at the hospital due to exacerbation
- •mechanically ventilated patients in the respiratory ICU
- •Age more than or equal to 18 years
排除标准
- •patients with active pulmonary tuberculosis
- •patients with allergic bronchopulmonary aspergillosis
- •patients who underwent interventional bronchoscopy for hemoptysis
- •age less than 18 years
研究组 & 干预措施
Gentamicin group
This arm will undergo bronchoscopic airway clearance followed by local instillation of gentamicin (80 mg once) and Budesonide (0.5 mg) once.
干预措施: Local instillation of gentamicin and Budesonide (Drug)
Gentamicin group
This arm will undergo bronchoscopic airway clearance followed by local instillation of gentamicin (80 mg once) and Budesonide (0.5 mg) once.
干预措施: Bronchoscopic mechanical secretion suction and lavage (Procedure)
Levofloxacin group
This arm will undergo bronchoscopic airway clearance followed by bronchoscopic instillation of levofloxacin 480 mg in isotonic saline during standardized bronchoscopy. And Budesonide (0.5 mg) once.
干预措施: Local instillation of Levofloxacin and Budesonide (Drug)
Levofloxacin group
This arm will undergo bronchoscopic airway clearance followed by bronchoscopic instillation of levofloxacin 480 mg in isotonic saline during standardized bronchoscopy. And Budesonide (0.5 mg) once.
干预措施: Bronchoscopic mechanical secretion suction and lavage (Procedure)
Sham group
Bronchoscopy for airway visualization only, no lavage or drug instillation (sham procedure).
干预措施: Sham Bronchoscopy (Procedure)
结局指标
主要结局
Days for weaning from mechanical ventilation
时间窗: one month
days of mechanical ventilation will be measured and compared between drug and conventional groups
次要结局
- The amount of sputum production per day(ml/day)(one year)
- 6-minute walking distance (meters)(one year)
- number of exacerbations (recorded number/year)(one year)
- Hospital admission(one year)
- Quality of life assessment in bronchiectasis patients(one year)
- Evaluation of anxiety in bronchiectasis patients using the Hamilton Anxiety rating Scale(one year)
- Evaluation of depression in bronchiectasis patients using the Hamilton Depression Rating Scale(one year)
研究者
Ali Abuzaid Ali
Assistant lecturer
Assiut University