A Randomized Sham-Controlled Trial of Bronchoscopic Levofloxacin and Gentamicin Versus Sham in Mechanically Ventilated Bronchiectasis: Acute and 1-Year Outcomes

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Egypt
Assiut university hospitals
RECRUITING
Asyut
Contact Information
Primary
Ali A Ali, MSc
aliabuzaid@aun.edu.eg
+2001064756136
Backup
Ahmad M shaddad, MD
Shaddad_ahmad@aun.edu.eg
+2001111171930
Time Frame
Start Date: 2023-10-15
Estimated Completion Date: 2027-02-01
Participants
Target number of participants: 315
Treatments
Experimental: Gentamicin group
This arm will undergo bronchoscopic airway clearance followed by local instillation of gentamicin (80 mg once) and Budesonide (0.5 mg) once.
Experimental: 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.
Sham_comparator: Sham group
Bronchoscopy for airway visualization only, no lavage or drug instillation (sham procedure).
Related Therapeutic Areas
Sponsors
Leads: Assiut University

This content was sourced from clinicaltrials.gov