Brief Title
Macrolide Mediates Pulmonary Infection of Pseudomonas Aeruginosa
Official Title
Macrolide Mediates Pulmonary Infection of Pseudomonas Aeruginosa Via NLRC4 Inflammasome Signaling Pathway
Brief Summary
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.
Detailed Description
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.
Study Type
Interventional
Primary Outcome
IL-18 in plasma
Condition
Bronchiectasis
Intervention
Azithromycin
Study Arms / Comparison Groups
Azithromycin group
Description: Patients with non-cystic bronchiectasis were treated with azithromycin. The intervention was 500mg daily for three to five days.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
71
Start Date
January 2014
Completion Date
January 2016
Primary Completion Date
January 2016
Eligibility Criteria
Inclusion Criteria:
1. Able to provide written informed consent.
2. Confirmed diagnosis of bronchiectasis by HRCT.
3. Aged 18-85 years.
Exclusion Criteria:
1. Bronchiectasis as a result of CF or active tuberculosis or non-tuberculous
mycobacterial (NTM) infection.
2. Allergy to macrolide antibiotics
3. Any history of severe cardiopulmonary dysfunction, eg. left heart failure, Unstable
cardiac arrhythmias
4. pregnant or nursing
5. hypogammaglobulinemia or other autoimmune disease 6. diagnosed with ABPA
Gender
All
Ages
18 Years - 85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Jin-Fu Xu, PhD, ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT02491723
Organization ID
20150619
Responsible Party
Sponsor-Investigator
Study Sponsor
Jin-Fu Xu
Study Sponsor
Jin-Fu Xu, PhD, Study Director, Shanghai Pulmonary Hospital, Shanghai, China
Verification Date
October 2016