Macrolide Mediates Pulmonary Infection of Pseudomonas Aeruginosa

It is acknowledged that IL-18, as a product of the inflammasome, is involved in host defence against viral and bacterial stimuli by modulating the immune response. The aim of this study was to determine IL-18 levels in serum of patients with Bronchiectasis and to investigate whether macrolide attenuate its levels.

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Key information

Conditions

Bronchiectasis Bronchial Diseases Respiratory Tract Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

About this study

Non-cystic fibrosis bronchiectasis is a respiratory disease characterized by persistent airway inflammation and dilation of bronchial wall driven by various causes. Patients with bronchiectasis suffer from excessive sputum production, recurrent exacerbations, and progressive airway destruction. It was reported that 30%-40% patients were infected with Pseudomonas aeruginosa. Major therapy for bronchiectasis is focused on breaking the "vicious cycle" of mucus stasis, infection, inflammation, and airway destruction. Currently a number of clinical trials have showed that macrolide effectively used in the treatment of non-CF bronchiectasis. Evidence has indicated that 14- and 15-membered ring macrolides possess immunomodulation and anti-inflammatory functions beyond their antimicrobial properties. However, the underlying mechanisms that account for the anti-inflammatory actions of macrolides have not yet to be elucidated, and the activities do not appear to be controlled by a single mechanism.Interleukin-18 (IL-18), along with interleukin-1b (IL-1b), is produced by inflammasomes when activated by a number of pathogen, environmental or host-derived danger signals. Inflammasomes are innate immune regulatory protein complexes which seem to play a key role in the host immune response of patients with Bronchiectasis. The aim of this study was to determine IL-18 levels in serum of patients with Bronchiectasis and to investigate whether macrolide could attenuate its levels.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Able to provide written informed consent.
Confirmed diagnosis of bronchiectasis by HRCT.
Aged 18-85 years.

Exclusion criteria

Bronchiectasis as a result of CF or active tuberculosis or non-tuberculous mycobacterial (NTM) infection.
Allergy to macrolide antibiotics
Any history of severe cardiopulmonary dysfunction, eg. left heart failure, Unstable cardiac arrhythmias
pregnant or nursing
hypogammaglobulinemia or other autoimmune disease 6. diagnosed with ABPA

Treatment and study plan

Azithromycin

Drug

Patients with bronchiectasis treated with Azithromycin for three to five days.

Other names: macrolide

Primary outcomes

IL-18 in plasma

Time frame: after 3-5 days treatment of Azithromycin immediately

Sponsors and collaborators

Lead sponsor

Jin-Fu Xu

Other

Registry information

Official study title

Macrolide Mediates Pulmonary Infection of Pseudomonas Aeruginosa Via NLRC4 Inflammasome Signaling Pathway

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Jul 8, 2015
Registry last updated: Oct 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed