Using Gentamicin and Dexamethasone for Bronchiectasis Treatment
A Randomized Sham-Controlled Trial of Bronchoscopic Levofloxacin and Gentamicin Versus Sham in Mechanically Ventilated Bronchiectasis: Acute and 1-Year Outcomes
This study tests whether using gentamicin and dexamethasone can help people with bronchiectasis who are on mechanical ventilation feel better and breathe easier during acute flare-ups.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 315 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assiut University Academic / other |
| Locations | 1 site (Asyut) |
| Trial ID | NCT06209047 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of local instillation of gentamicin and dexamethasone in patients with bronchiectasis experiencing acute exacerbations while on mechanical ventilation. The study aims to improve mucociliary clearance, reduce bacterial colonization, and alleviate airway inflammation through targeted treatment. Participants will undergo bronchoscopic airway clearance followed by the instillation of the medications to assess their impact on lung function and quality of life. The trial focuses on patients who require antibiotic treatment in a respiratory ICU setting.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with confirmed bronchiectasis and acute exacerbations requiring hospitalization.
Not a fit: Patients with active pulmonary tuberculosis or allergic bronchopulmonary aspergillosis may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this approach could significantly reduce exacerbations and improve the quality of life for patients with bronchiectasis.
How similar studies have performed: While the specific combination of gentamicin and dexamethasone for bronchiectasis is novel, similar approaches targeting bacterial colonization and inflammation have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Asyut
- Assiut university hospitals — Asyut, Egypt (Recruiting)
Study contacts
- Principal investigator: Ali A Ali, MSc — Assiut University
- Study coordinator: Ali A Ali, MSc
- Email: aliabuzaid@aun.edu.eg
- Phone: +2001064756136
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.