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

NCT ID: NCT06209047

Last Updated: 2025-07-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 315 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-15
• Study Completion Date: 2027-02-01

Brief 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.

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.

Conditions

Bronchiectasis With Acute Exacerbation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Gentamicin group

This arm will undergo bronchoscopic airway clearance followed by local instillation of gentamicin (80 mg once) and Budesonide (0.5 mg) once.

Group Type: EXPERIMENTAL

Local instillation of gentamicin and Budesonide

Intervention Type: DRUG

Bronchoscopic local instillation of gentamicin and Budesonide

Bronchoscopic mechanical secretion suction and lavage

Intervention Type: PROCEDURE

Bronchoscopic mechanical secretion suction and lavage

Levofloxacin group

This arm will undergo bronchoscopic airway clearance followed by bronchoscopic instillation of levofloxacin 480 mg in isotonic saline during standardized bronchoscopy. And Budesonide (0.5 mg) once.

Group Type: EXPERIMENTAL

Local instillation of Levofloxacin and Budesonide

Intervention Type: DRUG

Bronchoscopic local instillation of Levofloxacin and Budesonide

Bronchoscopic mechanical secretion suction and lavage

Intervention Type: PROCEDURE

Bronchoscopic mechanical secretion suction and lavage

Sham group

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

Group Type: SHAM_COMPARATOR

Sham Bronchoscopy

Intervention Type: PROCEDURE

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

Interventions

Local instillation of gentamicin and Budesonide

Bronchoscopic local instillation of gentamicin and Budesonide

Intervention Type: DRUG

Local instillation of Levofloxacin and Budesonide

Bronchoscopic local instillation of Levofloxacin and Budesonide

Intervention Type: DRUG

Bronchoscopic mechanical secretion suction and lavage

Bronchoscopic mechanical secretion suction and lavage

Intervention Type: PROCEDURE

Sham Bronchoscopy

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

Intervention Type: PROCEDURE

Other Intervention Names

Bronchoscopic instillation of gentamicin and steroids; Bronchoscopic instillation of levofloxacin and steroids; Masking intervention

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ali Abuzaid Ali

Assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ali A Ali, MSc

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Aliae A Hussien, MD

Role: STUDY_CHAIR

Assiut University

Ahmad M Shaddad, MD

Role: STUDY_DIRECTOR

Assiut University

Maiada K Hashem, MD

Role: STUDY_DIRECTOR

Assiut University

Locations

Assiut university hospitals

Asyut, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ali A Ali, MSc

Role: CONTACT

aliabuzaid@aun.edu.eg

+2001064756136

Ahmad M shaddad, MD

Role: CONTACT

Shaddad_ahmad@aun.edu.eg

+2001111171930

Facility Contacts

Ali A Ali, MSc

Role: primary

aliabuzaid@aun.edu.eg

01064756136

References

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Reference Type: RESULT

PMID: 17931847 (View on PubMed)

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.

Reference Type: RESULT

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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.

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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.

Reference Type: RESULT

PMID: 23898922 (View on PubMed)

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.

Reference Type: RESULT

PMID: 30215383 (View on PubMed)

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 bronchiectasis. Eur Respir J. 2017 Sep 9;50(3):1700629. doi: 10.1183/13993003.00629-2017. Print 2017 Sep.

Reference Type: RESULT

PMID: 28889110 (View on PubMed)

Other Identifiers

AU-12578383

Identifier Type: -

Identifier Source: org_study_id