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

NCT06209047 | Recruiting Phase 4

• 1 other identifier: AU-12578383
• Study Type: interventional
• Target: 315
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiectasis With Acute Exacerbation

Keywords

Bronchiectasis; Bronchoscopy; Levofloxacin; Gentamicins; Steroids

Outcome Measures

Primary Outcomes (1)

• Days for weaning from mechanical ventilation

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

  one month

Secondary Outcomes (7)

• The amount of sputum production per day(ml/day)

  one year

• 6-minute walking distance (meters)

  one year

• number of exacerbations (recorded number/year)

  one year

• Hospital admission

  one year

• Quality of life assessment in bronchiectasis patients

  one year

Study Arms (3)

Gentamicin group

EXPERIMENTAL

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

Drug: Local instillation of gentamicin and Budesonide; Procedure: Bronchoscopic mechanical secretion suction and lavage

Levofloxacin group

EXPERIMENTAL

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.

Drug: Local instillation of Levofloxacin and Budesonide; Procedure: Bronchoscopic mechanical secretion suction and lavage

Sham group

SHAM COMPARATOR

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

Procedure: Sham Bronchoscopy

Interventions

Local instillation of gentamicin and Budesonide DRUG

Bronchoscopic local instillation of gentamicin and Budesonide

Also known as: Bronchoscopic instillation of gentamicin and steroids

Gentamicin group

Local instillation of Levofloxacin and Budesonide DRUG

Bronchoscopic local instillation of Levofloxacin and Budesonide

Also known as: Bronchoscopic instillation of levofloxacin and steroids

Levofloxacin group

Bronchoscopic mechanical secretion suction and lavage PROCEDURE

Bronchoscopic mechanical secretion suction and lavage

Gentamicin group; Levofloxacin group

Sham Bronchoscopy PROCEDURE

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

Also known as: Masking intervention

Sham group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university hospitals

Asyut, 71515, Egypt

RECRUITING

Related Publications (6)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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.

  PMID: 28889110 RESULT

MeSH Terms

Conditions

Bronchiectasis

Interventions

Budesonide; Steroids; Therapeutic Irrigation

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Fused-Ring Compounds; Polycyclic Compounds; Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation; Investigative Techniques

Study Officials

• Ali A Ali, MSc

  Assiut University

  PRINCIPAL INVESTIGATOR

• Aliae A Hussien, MD

  Assiut University

  STUDY CHAIR

• Ahmad M Shaddad, MD

  Assiut University

  STUDY DIRECTOR

• Maiada K Hashem, MD

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Ali A Ali, MSc

CONTACT

+2001064756136; aliabuzaid@aun.edu.eg

Ahmad M shaddad, MD

CONTACT

+2001111171930; Shaddad_ahmad@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) All participants, clinical care providers (including bedside staff), investigators, and outcomes assessors will be blinded to group allocation. The use of a sham bronchoscopic procedure in the control arm ensures that all patients undergo a procedure of similar appearance and duration, minimizing the risk of performance and detection bias. Unblinding will only occur in the event of medically necessary interventions during the sham procedure, which will be documented as protocol deviations while maintaining the intention-to-treat analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Model Details: Arm 1: Levofloxacin Bronchoscopic instillation of levofloxacin 500 mg in isotonic saline during standardized bronchoscopy. Arm 2: Gentamicin Bronchoscopic instillation of gentamicin 80 mg in isotonic saline during standardized bronchoscopy. Arm 3: Sham Bronchoscopy for airway visualization only, no lavage or drug instillation (sham procedure).

Study Record Dates

• First Submitted: December 26, 2023
• First Posted: January 17, 2024
• Study Start: October 15, 2023
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 12 months after publication of the primary (acute phase) results, for a period of 3 years. Data from both the acute hospital phase and the 1-year follow-up phase will be available after publication of the respective results in peer-reviewed journals.
• Access Criteria: De-identified individual participant data (IPD) will be made available to qualified researchers following publication of the primary and long-term results. Access will be granted for methodologically sound proposals that are consistent with the approved protocol and ethical standards. All requests must include a clear scientific rationale, analysis plan, and evidence of appropriate institutional review board (IRB) approval or waiver. Data will be shared under a data use agreement, which ensures: No attempt to re-identify participants, Use of data only for the approved research purpose, Compliance with all applicable privacy and security regulations. Requests will be reviewed by the trial's Steering Committee and Data Access Committee. Approved researchers will receive de-identified, PID-linked datasets and supporting documentation. To request data access, interested parties should contact the Principal Investigator.

Locations

EG (1)