Macrolide Mediates Pulmonary Infection of Pseudomonas Aeruginosa

October 12, 2016 updated by: Jin-Fu Xu

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • Shanghai Pulmonary Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Azithromycin group
Patients with non-cystic bronchiectasis were treated with azithromycin. The intervention was 500mg daily for three to five days.
Drug: Azithromycin
Patients with bronchiectasis treated with Azithromycin for three to five days.
Other Names:
  • macrolide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
IL-18 in plasma
Time Frame: after 3-5 days treatment of Azithromycin immediately
after 3-5 days treatment of Azithromycin immediately

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jin-Fu Xu

Investigators

  • Study Director: Jin-Fu Xu, PhD, Shanghai Pulmonary Hospital, Shanghai, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

July 3, 2015

First Submitted That Met QC Criteria

July 3, 2015

First Posted (Estimate)

July 8, 2015

Study Record Updates

Last Update Posted (Estimate)

October 14, 2016

Last Update Submitted That Met QC Criteria

October 12, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20150619

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bronchiectasis

Clinical Trials on Azithromycin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe