Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Aztreonam for Inhalation Solution (AZLI) for the Treatment of Exacerbations of Cystic Fibrosis (AZTEC-CF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02894684
Recruitment Status : Completed
First Posted : September 9, 2016
Last Update Posted : October 7, 2019
Sponsor:
Collaborator:
University of Liverpool
Information provided by (Responsible Party):
Liverpool Heart and Chest Hospital NHS Foundation Trust

Brief Summary:
This study evaluates the role of AZLI in the treatment of acute pulmonary exacerbations of CF. For consecutive exacerbations patients will receive AZLI + IV Colistin, or two IV anti-pseudomonals.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Infection Pseudomonas Drug: Aztreonam Drug: Standard Care Phase 4

Detailed Description:

AZLI, marketed as Cayston, is an inhaled beta-lactam antibiotic. It has a license for the chronic suppression of Pseudomonas aeruginosa (PA). Current standard practice dictates the use of two IV antipseudomonal antibiotics for the treatment of acute pulmonary exacerbations. The increasing survival, and hence population, in CF means that newer antimicrobial strategies are required in order to manage antimicrobial resistance, minimise adverse systemic effects of heavy antimicrobial exposure and also make effective use of resources. Inhaled antibiotics are commonly used in the chronic suppression of PA yet their use has not been thoroughly investigated in acute pulmonary exacerbation. Inhaled antibiotics deliver their drugs directly to the target-site with minimal systemic absorbance, making them an attractive candidate for treatment of acute exacerbations.

Recently, it has become apparent that the bacterial community is much more complex than initially thought. The microbiome, a term used to describe the polymicrobial community in the lungs, has become apparent due to the use of modern culture-independent methods to detect bacteria. The microbiome changes in composition and structure around the time of exacerbations and in response to treatment, although these changes have not been prospectively characterised.

We have designed an open-label randomised, controlled cross-over trial to investigate the clinical effectiveness of of AZLI in the treatment of acute pulmonary exacerbation, whilst simultaneously comparing the effect inhaled and intravenous antibiotics have on the microbiome.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Aztreonam for Inhalation Solution (AZLI) for the Treatment of Exacerbations of Cystic Fibrosis. An Randomised, Crossover Pilot Study of AZLI Plus Intravenous Colistin® Versus Standard Dual Intravenous Therapy
Actual Study Start Date : January 2017
Actual Primary Completion Date : February 2019
Actual Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis
Drug Information available for: Aztreonam

Arm Intervention/treatment
Experimental: AZLI then Standard Care
Upon first exacerbation this arm will receive AZLI, on their second they will receive standard care
Drug: Aztreonam
14 days of AZLI: 75mg TDS PLUS IV Colistin
Other Names:
  • Cayston
  • AZLI

Drug: Standard Care
14 days of IV Colistin plus one of Tazocin/Ceftazidime/Meropenem/Aztreonam/Fosfomycin

Active Comparator: Standard Care then AZLI
Upon first exacerbation this arm will receive standard care, on the second exacerbation this arm will receive AZLI
Drug: Aztreonam
14 days of AZLI: 75mg TDS PLUS IV Colistin
Other Names:
  • Cayston
  • AZLI

Drug: Standard Care
14 days of IV Colistin plus one of Tazocin/Ceftazidime/Meropenem/Aztreonam/Fosfomycin




Primary Outcome Measures :
  1. Average actual change in percent predicted forced expiratory volume at 1 second (FEV1) from Day 1 to Day 14 [ Time Frame: 14 days ]
    The actual change in FEV1 (%predicted) from Day 1 of admission to Day 7 & Day 14


Secondary Outcome Measures :
  1. Time to first pulmonary exacerbation [ Time Frame: 12 months ]
    Time from discharge to next pulmonary exacerbation

  2. Average change from baseline in the Cystic Fibrosis Quality of Life Questionnaire (CFQ-R) [ Time Frame: 14 days ]
    Average change from baseline (Day 1) in the CFQ-R Respiratory Symptom Score (RSS) at the end (Day 14) of each arm of the study

  3. Microbiome changes [ Time Frame: 14 days ]
    Changes in the structure and composition of the microbiome at the beginning and end of each treatment arm

  4. PA sputum counts [ Time Frame: 14 days ]
    Changes in sputum PA counts from the beginning to end of each treatment arm.

  5. Antimicrobial resistance [ Time Frame: 14 days ]
    Prevalence of resistance to antibiotics at the beginning and end of each treatment arm.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Confirmed diagnosis of CF
  2. Patients aged 18 - 65 years of age who can give informed consent
  3. FEV1 >25% or <75% predicted (in keeping with Cayston® license)
  4. Admitted to the Liverpool Heart & Chest Hospital with an exacerbation of CF pulmonary disease
  5. Presence of PA in lower respiratory tract cultures in the 6 months prior

Exclusion Criteria:

  1. Documented allergy to beta-lactam antibiotics or IV Colistin
  2. Growth of Burkholderia Cepacia Complex (BCC) within 2 years
  3. Pregnancy
  4. Previous organ transplant
  5. Receiving other clinical trial medication
  6. Already prescribed regular Cayston®

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): NCT02894684


Locations
Layout table for location information
United Kingdom
Liverpool Heart & Chest Hospital NHS Trust
Liverpool, United Kingdom, L3 9BZ
Sponsors and Collaborators
Liverpool Heart and Chest Hospital NHS Foundation Trust
University of Liverpool
Investigators
Layout table for investigator information
Principal Investigator: Freddy Frost, BMBS BMedSci Liverpool Heart & Chest Hospital NHS Foundation Trust
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Liverpool Heart and Chest Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02894684    
Other Study ID Numbers: 2016AZLIND001
First Posted: September 9, 2016    Key Record Dates
Last Update Posted: October 7, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Aztreonam
Anti-Bacterial Agents
Anti-Infective Agents