NCT02894684

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2017

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 9, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

October 7, 2019

Status Verified

October 1, 2019

Enrollment Period

2.1 years

First QC Date

September 1, 2016

Last Update Submit

October 3, 2019

Conditions

Cystic FibrosisInfectionPseudomonas

Outcome Measures

Primary Outcomes (1)

  • Average actual change in percent predicted forced expiratory volume at 1 second (FEV1) from Day 1 to Day 14

    The actual change in FEV1 (%predicted) from Day 1 of admission to Day 7 \& Day 14

    14 days

Secondary Outcomes (5)

  • Time to first pulmonary exacerbation

    12 months

  • Average change from baseline in the Cystic Fibrosis Quality of Life Questionnaire (CFQ-R)

    14 days

  • Microbiome changes

    14 days

  • PA sputum counts

    14 days

  • Antimicrobial resistance

    14 days

Study Arms (2)

AZLI then Standard Care

EXPERIMENTAL

Upon first exacerbation this arm will receive AZLI, on their second they will receive standard care

Drug: AztreonamDrug: Standard Care

Standard Care then AZLI

ACTIVE COMPARATOR

Upon first exacerbation this arm will receive standard care, on the second exacerbation this arm will receive AZLI

Drug: AztreonamDrug: Standard Care

Interventions

AztreonamDRUG

14 days of AZLI: 75mg TDS PLUS IV Colistin

Also known as: Cayston, AZLI
AZLI then Standard CareStandard Care then AZLI
Standard CareDRUG

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

AZLI then Standard CareStandard Care then AZLI

Eligibility Criteria

Age16 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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®

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liverpool Heart & Chest Hospital NHS Trust

Liverpool, L3 9BZ, United Kingdom

Location

Related Publications (1)

  • Frost F, Young GR, Wright L, Miah N, Smith DL, Winstanley C, Walshaw MJ, Fothergill JL, Nazareth D. The clinical and microbiological utility of inhaled aztreonam lysine for the treatment of acute pulmonary exacerbations of cystic fibrosis: An open-label randomised crossover study (AZTEC-CF). J Cyst Fibros. 2021 Nov;20(6):994-1002. doi: 10.1016/j.jcf.2020.12.012. Epub 2021 Jan 7.

    PMID: 33358119DERIVED

MeSH Terms

Conditions

Cystic FibrosisInfectionsPseudomonas Infections

Interventions

AztreonamStandard of Care

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Monobactamsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Freddy Frost, BMBS BMedSci

    Liverpool Heart & Chest Hospital NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2016

First Posted

September 9, 2016

Study Start

January 1, 2017

Primary Completion

February 1, 2019

Study Completion

September 1, 2019

Last Updated

October 7, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)