Bronchiectasis With Acute Exacerbation
Conditions
Keywords
Bronchiectasis, Bronchoscopy, Levofloxacin, Gentamicins, Steroids
Brief summary
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.
Detailed description
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.
Interventions
DRUGLocal instillation of gentamicin and Budesonide
Bronchoscopic local instillation of gentamicin and Budesonide
DRUGLocal instillation of Levofloxacin and Budesonide
Bronchoscopic local instillation of Levofloxacin and Budesonide
PROCEDUREBronchoscopic mechanical secretion suction and lavage
Bronchoscopic mechanical secretion suction and lavage
PROCEDURESham Bronchoscopy
Bronchoscopy for airway visualization only, no lavage or drug instillation (sham procedure).
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
Arm 1: Levofloxacin Bronchoscopic instillation of levofloxacin 500 mg in isotonic saline during standardized bronchoscopy. Arm 2: Gentamicin Bronchoscopic instillation of gentamicin 80 mg in isotonic saline during standardized bronchoscopy. Arm 3: Sham Bronchoscopy for airway visualization only, no lavage or drug instillation (sham procedure).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* patients with active pulmonary tuberculosis * patients with allergic bronchopulmonary aspergillosis * patients who underwent interventional bronchoscopy for hemoptysis * age less than 18 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Days for weaning from mechanical ventilation | one month | days of mechanical ventilation will be measured and compared between drug and conventional groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 6-minute walking distance (meters) | one year | The total recorded distance in 6 minutes in meters |
| number of exacerbations (recorded number/year) | one year | The number of reported exacerbations in one year |
| Hospital admission | one year | The number of reported hospital admissions in one year |
| The amount of sputum production per day(ml/day) | one year | The total amount of sputum per day will be measured and compared between the drug and conventional groups |
| Evaluation of anxiety in bronchiectasis patients using the Hamilton Anxiety rating Scale | one year | The anxiety in bronchiectasis patients will be measured using the Hamilton Anxiety rating scale, which consists of 14 items ranging from 0 - 56 (higher equals more anxiety). |
| Evaluation of depression in bronchiectasis patients using the Hamilton Depression Rating Scale | one year | The depression in bronchiectasis patients will be measured using the Hamilton Depression rating scale, which consists of 17 items ranging from 0 - 52 (higher equals more depression). |
| Quality of life assessment in bronchiectasis patients | one year | The quality of life assessment in bronchiectasis patients using patient-reported outcome measures (Quality of Life Bronchiectasis questionnaire). It consists of 8 domains scored on a 0 - 100 scale (higher equals better QoL) |
Countries
Egypt
Contacts
Primary ContactAli A Ali, MSc
Backup ContactAhmad M shaddad, MD
Outcome results
None listed