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

NCT06209047 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 315

Last updated 2025-07-17

No results posted yet for this study

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.

Conditions

  • Bronchiectasis With Acute Exacerbation

Interventions

DRUG

Local instillation of gentamicin and Budesonide

Bronchoscopic local instillation of gentamicin and Budesonide

DRUG

Local instillation of Levofloxacin and Budesonide

Bronchoscopic local instillation of Levofloxacin and Budesonide

PROCEDURE

Bronchoscopic mechanical secretion suction and lavage

Bronchoscopic mechanical secretion suction and lavage

PROCEDURE

Sham Bronchoscopy

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

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Principal Investigators

  • Ali A Ali, MSc · Assiut University

  • Aliae A Hussien, MD · Assiut University

  • Ahmad M Shaddad, MD · Assiut University

  • Maiada K Hashem, MD · Assiut University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-15
Primary Completion
2026-05-15
Completion
2027-02-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06209047 on ClinicalTrials.gov