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Bronchoscopic Levofloxacin, Gentamicin, or Sham for Acute Exacerbation of Bronchiectasis

StatusRecruiting
PhasePhase 4
Started2023-10-15
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 17, 2025 (before its estimated May 15, 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2025-07-13
Study Identification, Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing v2
Primary completion date2025-06→2026-05-15
Completion date2025-12→2027-02-01
Start date2024-01-25→2023-10-15
Enrollment target70→315
Study arms2→3
Interventionsbronchoscopic airway clearance followed by local instillation of gentamicin and dexamethasone (Drug)→Bronchoscopic mechanical secretion suction and lavage (Procedure), Local instillation of Levofloxacin and Budesonide (Drug), Local…
Eligibility criteria+10 characters
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 ventillatedventilated patients atin the respiratory ICU Age more than or equal to 18 years Exclusion Criteria: patients with active pulmonary [...]
Secondary endpoints2 to 7 entries
DaysThe amount of intensivesputum careproduction unitper day(ICUml/day) 6-minute andwalking hospitaldistance stay(meters) daysnumber forof recurrenceexacerbations (recorded number/year) Hospital admission Quality of life assessment in bronchiectasis patients Evaluation of anxiety in bronchiectasis patients using the Hamilton Anxiety rating Scale Evaluation of depression in bronchiectasis patients using the Hamilton Depression Rating Scale
Primary endpoints2 to 1 entries
The amount of sputum production per day(ml/day)
Study description+34 characters
bronchiectasisBronchiectasis is a chronic suppurative and inflammatory lung disease of d [...] nea. Clinically, the major manifestations of bronchiectasis areinclude chronic cough with purulent sputum, dyspnea, and fatigue, thatwhich maycan significantly diminish the patients' quality of life. The frequency of exacerbationexacerbations and the 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 exacerbationexacerbations, prevent complications, and improve the quality of life. Long-term instillation of gentamici [...] [...]
Study sitesdetails revised at 1 of 1 site
Study title-9 characters
InstillationBronchoscopic Levofloxacin, Gentamicin, or Sham for Acute Exacerbation of Gentamicin and Dexamethasone in Bronchiectasis Compared to Conventional Treatment
2024-08-03
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2025-01→2025-06
Completion date2025-02→2025-12
Start dateestimated 2024-01→confirmed 2024-01-25
Study sites0→1
2024-01-13
Original filing
Assiut University
1,604 trials monitored
See 18 trials at risk
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.
Trial Details
NCT Number NCT06209047
Lead Sponsor Assiut University
Conditions Bronchiectasis With Acute Exacerbation
Enrollment 315 participants
Start Date 2023-10-15
Primary Completion 2026-05-15 (estimated)
Study Completion 2027-02-01 (estimated)
Updated on ClinicalTrials.gov 2025-07-17