deltatrials
Recruiting PHASE4 INTERVENTIONAL 3-arm NCT06209047

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

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

Sponsor: Assiut University

Updated 5 times since 2024 Last updated: Jul 13, 2025 Started: Oct 15, 2023 Primary completion: May 15, 2026 Completion: Feb 1, 2027
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE4 clinical study on Bronchiectasis With Acute Exacerbation, this trial is actively recruiting participants. The trial is conducted by Assiut University and has accumulated 5 data snapshots since 2023. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Study Description(click to expand)

Bronchiectasis is a chronic suppurative and inflammatory lung disease of diverse etiology characterized by pathological and irreversible dilatation of the bronchial tree. The impairment of the mucociliary clearance, which results from chronic airway inflammation, may cause long-term colonization or recurrent infection of bacteria, especially Pseudomonas aeruginosa (PA), while bacterial colonization and recurrent infection can aggravate airway inflammation. Sputum retention caused by the impairment of mucociliary clearance can result in mucous plugs, which in turn contribute to airflow obstruction and dyspnea. Clinically, the major manifestations of bronchiectasis include chronic cough with purulent sputum, dyspnea, and fatigue, which can significantly diminish patients' quality of life. The frequency of exacerbations and 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 exacerbations, prevent complications, and improve the quality of life. Long-term instillation of antibiotics and steroids can reduce the concentration of bacteria in the airways, decrease sputum production, attenuate lung function decline, and reduce acute pulmonary exacerbations without nephrotoxicity or ototoxicity. Dexamethasone is one of the most common glucocorticoids that can inhibit the expression levels of inflammatory factors in the airway and reduce the secretion of airway mucus....

Bronchiectasis is a chronic suppurative and inflammatory lung disease of diverse etiology characterized by pathological and irreversible dilatation of the bronchial tree. The impairment of the mucociliary clearance, which results from chronic airway inflammation, may cause long-term colonization or recurrent infection of bacteria, especially Pseudomonas aeruginosa (PA), while bacterial colonization and recurrent infection can aggravate airway inflammation. Sputum retention caused by the impairment of mucociliary clearance can result in mucous plugs, which in turn contribute to airflow obstruction and dyspnea.

Clinically, the major manifestations of bronchiectasis include chronic cough with purulent sputum, dyspnea, and fatigue, which can significantly diminish patients' quality of life. The frequency of exacerbations and 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 exacerbations, prevent complications, and improve the quality of life. Long-term instillation of antibiotics and steroids can reduce the concentration of bacteria in the airways, decrease sputum production, attenuate lung function decline, and reduce acute pulmonary exacerbations without nephrotoxicity or ototoxicity. Dexamethasone is one of the most common glucocorticoids that can inhibit the expression levels of inflammatory factors in the airway and reduce the secretion of airway mucus. Topical administration could also reduce the systemic side effects.

Status Flow

~Feb 2024 – ~Jul 2024 · 5 months · monthly snapshotNot Yet Recruiting~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Aug 2025 · 11 months · monthly snapshotRecruiting~Aug 2025 – ~Sep 2025 · 31 days · monthly snapshot~Sep 2025 – present · 7 months · monthly snapshotRecruiting

Change History

5 versions recorded
  1. Sep 2025 — Present [monthly]

    Recruiting PHASE4

  2. Aug 2025 — Sep 2025 [monthly]

    Recruiting PHASE4

  3. Sep 2024 — Aug 2025 [monthly]

    Recruiting PHASE4

    Status: Not Yet RecruitingRecruiting

  4. Jul 2024 — Sep 2024 [monthly]

    Not Yet Recruiting PHASE4

  5. Feb 2024 — Jul 2024 [monthly]

    Not Yet Recruiting PHASE4

    First recorded

Oct 2023

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Assiut University
Data source: Assiut University

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations