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NCT Number: NCT02894684

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

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.

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Key information

Conditions

Cystic Fibrosis Bacterial Infections Bacterial Infections and Mycoses Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Gram-Negative Bacterial Infections Infant, Newborn, Diseases Infection Infections Lung Diseases Pancreatic Diseases Pseudomonas Pseudomonas Infections Respiratory Tract Diseases

Age range

16 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Liverpool Heart & Chest Hospital NHS Trust

Liverpool, L3 9BZ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Aztreonam

Drug

14 days of AZLI: 75mg TDS PLUS IV Colistin

Other names: Cayston, AZLI

Standard care

Drug

14 days of IV Colistin plus one of Tazocin/Ceftazidime/Meropenem/Aztreonam/Fosfomycin

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Liverpool Heart and Chest Hospital NHS Foundation Trust

Other

Collaborators

  • University of Liverpool

Registry information

Official study 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

Acronym: AZTEC-CF

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 9, 2016
Registry last updated
Oct 7, 2019

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.

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