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

ConditionBronchiectasis With Acute Exacerbation
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssiut University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

patients with active pulmonary tuberculosis

patients with allergic bronchopulmonary aspergillosis

patients who underwent interventional bronchoscopy for hemoptysis

age less than 18 years

Trial design

Design model

Parallel

Treatments tested in this trial

  • Local instillation of gentamicin and Budesonide

    Drug

    Bronchoscopic local instillation of gentamicin and Budesonide

  • Local instillation of Levofloxacin and Budesonide

    Drug

    Bronchoscopic local instillation of Levofloxacin and Budesonide

  • Bronchoscopic mechanical secretion suction and lavage

    Procedure/Surgery

    Bronchoscopic mechanical secretion suction and lavage

  • Sham Bronchoscopy

    Procedure/Surgery

    Bronchoscopy for airway visualization only, no lavage or drug instillation (sham procedure).

Treatment groups

315 Participants
are divided into 3 treatment groups
Group A: Gentamicin groupExperimental treatment 2 interventions
Group B: Levofloxacin groupExperimental treatment 2 interventions
Group C: Sham groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Days for weaning from mechanical ventilation

days of mechanical ventilation will be measured and compared between drug and conventional groups

Time frame
one month

Secondary outcomes

1

The amount of sputum production per day(ml/day)

The total amount of sputum per day will be measured and compared between the drug and conventional groups

Time frame
one year
2

6-minute walking distance (meters)

The total recorded distance in 6 minutes in meters

Time frame
one year
3

number of exacerbations (recorded number/year)

The number of reported exacerbations in one year

Time frame
one year
4

Hospital admission

The number of reported hospital admissions in one year

Time frame
one year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov
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