NCT06209047 Bronchoscopic Levofloxacin, Gentamicin, or Sham for Acute Exacerbation of Bronchiectasis
| NCT ID | NCT06209047 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Assiut University |
| Condition | Bronchiectasis With Acute Exacerbation |
| Study Type | INTERVENTIONAL |
| Enrollment | 315 participants |
| Start Date | 2023-10-15 |
| Primary Completion | 2026-05-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 315 participants in total. It began in 2023-10-15 with a primary completion date of 2026-05-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Ali A Ali, MSc
PRINCIPAL INVESTIGATOR
Assiut University
Frequently Asked Questions
Who can join the NCT06209047 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bronchiectasis With Acute Exacerbation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06209047 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06209047 currently recruiting?
Yes, NCT06209047 is actively recruiting participants. Contact the research team at aliabuzaid@aun.edu.eg for enrollment information.
Where is the NCT06209047 trial being conducted?
This trial is being conducted at Asyut, Egypt.
Who is sponsoring the NCT06209047 clinical trial?
NCT06209047 is sponsored by Assiut University. The principal investigator is Ali A Ali, MSc at Assiut University. The trial plans to enroll 315 participants.