Clinical trial NCT06209047: Instillation of Gentamicin and Dexamethasone in Bronchiectasis Compared to Conventional Treatment
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Bronchiectasis With Acute Exacerbation
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-01-17
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a randomized controlled study where we divide the patients in a randomized manner(simple un-restricted randomization) into 2 groups , one group will undergo airway clearance by bronchoscopy followed by local instillation of gentamicin and dexamethasone , the other group will receive only conventional treatment which include antibiotic treatment,suction through the endotracheal tube and physiotherapy but without local instillation of the drugs used in the other arm
Primary purpose: TREATMENT

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

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 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.

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 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

Primary outcomes:
measure: Days for weaning from mechanical ventilation
timeFrame: one year
measure: The amount of sputum production per day(ml/day)
timeFrame: one year
Secondary outcomes:
measure: Days of intensive care unit(ICU) and hospital stay
timeFrame: one year
measure: days for recurrence
timeFrame: one year
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university hospitals
Study officials:
name: A abuzaid
role: PRINCIPAL_INVESTIGATOR
name: A abdrabou
role: STUDY_CHAIR
name: Ah Shaddad
role: STUDY_DIRECTOR
name: M maiada
role: STUDY_DIRECTOR
References:
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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: 10.1164/rccm.201005-0756OC. Epub 2010 Sep 24.
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.
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.
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.
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, 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.