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Trial record 6 of 44 for:    "Bronchial Disease" | "Azithromycin"

Macrolide Mediates Pulmonary Infection of Pseudomonas Aeruginosa

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ClinicalTrials.gov Identifier: NCT02491723
Recruitment Status : Completed
First Posted : July 8, 2015
Last Update Posted : October 14, 2016
Sponsor:
Information provided by (Responsible Party):
Jin-Fu Xu, Shanghai Pulmonary Hospital, Shanghai, China

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.

Condition or disease Intervention/treatment Phase
Bronchiectasis Drug: Azithromycin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Macrolide Mediates Pulmonary Infection of Pseudomonas Aeruginosa Via NLRC4 Inflammasome Signaling Pathway
Study Start Date : January 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


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 Name: macrolide




Primary Outcome Measures :
  1. IL-18 in plasma [ Time Frame: after 3-5 days treatment of Azithromycin immediately ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02491723


Locations
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China, Shanghai
Shanghai Pulmonary Hospital
Shanghai, Shanghai, China, 200433
Sponsors and Collaborators
Jin-Fu Xu
Investigators
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Study Director: Jin-Fu Xu, PhD Shanghai Pulmonary Hospital, Shanghai, China

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Responsible Party: Jin-Fu Xu, deputy director, Shanghai Pulmonary Hospital, Shanghai, China
ClinicalTrials.gov Identifier: NCT02491723     History of Changes
Other Study ID Numbers: 20150619
First Posted: July 8, 2015    Key Record Dates
Last Update Posted: October 14, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
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Pseudomonas Infections
Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases
Gram-Negative Bacterial Infections
Bacterial Infections