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NCT Number: NCT06209047

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Assiut university hospitals

Asyut, 71515, Egypt

Location status: Recruiting

Location contact

Ahmad M Shaddad, MD

PRINCIPAL_INVESTIGATOR

Ali A Ali, MSc

CONTACT

[email protected]

01064756136

Ali A Ali, MSc

PRINCIPAL_INVESTIGATOR

Aliae A Hussien, MD

PRINCIPAL_INVESTIGATOR

Maiada K Hashem, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 ventilated patients in the respiratory ICU
  • Age more than or equal to 18 years

Exclusion criteria

  • patients with active pulmonary tuberculosis
  • patients with allergic bronchopulmonary aspergillosis
  • patients who underwent interventional bronchoscopy for hemoptysis
  • age less than 18 years

Treatment and study plan

Local instillation of gentamicin and Budesonide

Drug

Bronchoscopic local instillation of gentamicin and Budesonide

Other names: Bronchoscopic instillation of gentamicin and steroids

Local instillation of Levofloxacin and Budesonide

Drug

Bronchoscopic local instillation of Levofloxacin and Budesonide

Other names: Bronchoscopic instillation of levofloxacin and steroids

Bronchoscopic mechanical secretion suction and lavage

Procedure

Bronchoscopic mechanical secretion suction and lavage

Sham Bronchoscopy

Procedure

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

Other names: Masking intervention

Primary outcomes

  1. Days for weaning from mechanical ventilation

    Time frame: one month

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

Secondary outcomes

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

    Time frame: one year

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

  2. 6-minute walking distance (meters)

    Time frame: one year

    The total recorded distance in 6 minutes in meters

  3. number of exacerbations (recorded number/year)

    Time frame: one year

    The number of reported exacerbations in one year

  4. Hospital admission

    Time frame: one year

    The number of reported hospital admissions in one year

  5. Quality of life assessment in bronchiectasis patients

    Time frame: one year

    The quality of life assessment in bronchiectasis patients using patient-reported outcome measures (Quality of Life Bronchiectasis questionnaire). It consists of 8 domains scored on a 0 - 100 scale (higher equals better QoL)

  6. Evaluation of anxiety in bronchiectasis patients using the Hamilton Anxiety rating Scale

    Time frame: one year

    The anxiety in bronchiectasis patients will be measured using the Hamilton Anxiety rating scale, which consists of 14 items ranging from 0 - 56 (higher equals more anxiety).

  7. Evaluation of depression in bronchiectasis patients using the Hamilton Depression Rating Scale

    Time frame: one year

    The depression in bronchiectasis patients will be measured using the Hamilton Depression rating scale, which consists of 17 items ranging from 0 - 52 (higher equals more depression).

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmad M shaddad, MD

CONTACT

[email protected]

+2001111171930

Ali A Ali, MSc

CONTACT

[email protected]

+2001064756136

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jan 17, 2024
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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