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Recruiting NCT06209047

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

Phase IV Interventional Bronchiectasis With Acute Exacerbation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Local instillation of gentamicin and Budesonide, Local instillation of Levofloxacin and Budesonide, Bronchoscopic mechanical secretion suction and lavage, Sham Bronchoscopy.
Who it may be relevant to
Registry conditions: Bronchiectasis With Acute Exacerbation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

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.

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).

Primary outcome measures

  • Days for weaning from mechanical ventilation [Time frame: one month]
Secondary outcome measures (7)
  • The amount of sputum production per day(ml/day) [Time frame: one year]
  • 6-minute walking distance (meters) [Time frame: one year]
  • number of exacerbations (recorded number/year) [Time frame: one year]
  • Hospital admission [Time frame: one year]
  • Quality of life assessment in bronchiectasis patients [Time frame: one year]
  • Evaluation of anxiety in bronchiectasis patients using the Hamilton Anxiety rating Scale [Time frame: one year]
  • Evaluation of depression in bronchiectasis patients using the Hamilton Depression Rating Scale [Time frame: one year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Assiut university hospitals — Asyut

Publications

  • Chan SC, Shum DK, Tipoe GL, Mak JC, Leung ET, Ip MS. Upregulation of ICAM-1 expression in bronchial epithelial cells by airway secretions in bronchiectasis. Respir Med. 2008 Feb;102(2):287-98. doi: 10.1016/j.rmed.2007.08.013. Epub 2007 Oct 10. PMID 17931847
  • Murray MP, Govan JR, Doherty CJ, Simpson AJ, Wilkinson TS, Chalmers JD, Greening AP, Haslett C, Hill AT. A randomized controlled trial of nebulized gentamicin in non-cystic fibrosis bronchiectasis. Am J Respir Crit Care Med. 2011 Feb 15;183(4):491-9. doi: 10.1164/rccm.201005-0756OC. Epub 2010 Sep 24. PMID 20870753
  • King PT, Holdsworth SR, Freezer NJ, Villanueva E, Holmes PW. Characterisation of the onset and presenting clinical features of adult bronchiectasis. Respir Med. 2006 Dec;100(12):2183-9. doi: 10.1016/j.rmed.2006.03.012. Epub 2006 May 2. PMID 16650970
  • McShane PJ, Naureckas ET, Tino G, Strek ME. Non-cystic fibrosis bronchiectasis. Am J Respir Crit Care Med. 2013 Sep 15;188(6):647-56. doi: 10.1164/rccm.201303-0411CI. PMID 23898922
  • Flume PA, Chalmers JD, Olivier KN. Advances in bronchiectasis: endotyping, genetics, microbiome, and disease heterogeneity. Lancet. 2018 Sep 8;392(10150):880-890. doi: 10.1016/S0140-6736(18)31767-7. PMID 30215383
  • Polverino E, Goeminne PC, McDonnell MJ, Aliberti S, Marshall SE, Loebinger MR, Murris M, Canton R, Torres A, Dimakou K, De Soyza A, Hill AT, Haworth CS, Vendrell M, Ringshausen FC, Subotic D, Wilson R, Vilaro J, Stallberg B, Welte T, Rohde G, Blasi F, Elborn S, Almagro M, Timothy A, Ruddy T, Tonia T, Rigau D, Chalmers JD. European Respiratory Society guidelines for the management of adult bronchie PMID 28889110

Identifiers

NCT: NCT06209047 · AU-12578383

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗