Instillation of Gentamicin and Dexamethasone in Bronchiectasis Compared to Conventional Treatment

Bronchiectasis With Acute Exacerbation Clinical Trial

Official title:

Safety and Efficacy of Local Instillation of Gentamicin and Dexamethasone Versus Conventional Treatment in Management of Acute Exacerbation of Bronchiectasis in Mechanically Ventilated Patients, a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06209047
• Other study ID #: gentamicin in bronchiectasis
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: January 2024
• Est. completion date: February 2025

Study information

• Verified date: January 2024
• Source: Assiut University
• Contact: A abuzaid
• Phone: +2001064756136
• Email: aliabuzaid[@]aun.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Safety and efficacy of local instillation of Gentamicin and dexamethasone in acute exacerbation of bronchiectasis in mechanically ventilated patients

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 are chronic cough with purulent sputum, dyspnea, and fatigue that may diminish the patients' quality of life. The frequency of exacerbation and the decline in lung function may lead to poor prognosis and decrease quality of life. The purpose of bronchiectasis management is to reduce exacerbation, prevent complications, and improve the quality of life. Long-term instillation of gentamicin 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 which 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: February 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients with bronchiectasis confirmed by high resolution CT chest(HRCT)
• patients with acute exacerbation of bronchiectasis who need antibiotic treatment at hospital due to exacerbation
• mechanically ventillated patients at respiratory ICU
• Age more than or equal 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

Related Conditions & MeSH terms

• Bronchiectasis
• Bronchiectasis With Acute Exacerbation

Intervention

Drug:
• bronchoscopic airway clearance followed by local instillation of gentamicin and dexamethasone
bronchoscopic airway clearance followed by local instillation of gentamicin and dexamethasone

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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: — View Citation

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, Elb — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days for weaning from mechanical ventilation	days of mechanical ventilation will be measured and compared between drug and conventional groups	one year
Primary	The amount of sputum production per day(ml/day)	the total amount of sputum per day will be measured and compared between drug and conventional groups	one year
Secondary	Days of intensive care unit(ICU) and hospital stay	days of ICU and hospital stay will be measured	one year
Secondary	days for recurrence	days for recurrence or next exacerbation will be measured	one year