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AZTEC-CF

Details

Therapeutic category
the type of treatment or therapy being studied. A therapy could range from a medication addressing a particular characteristic of CF to a device or activity e.g. exercise

Anti-Infective

Trial status

Closed to recruitment - in follow up

Participating Centres
Phase
the different stages involved in the development of a new medication. Phase I focuses on initial safety in people. Phase 2 evaluates safety, correct dose and early signs of whether the medication works. Phase 3 is the stage before medication licensing and looks at safety and medication effectiveness. Phase 4 evaluates longer term use of a medication after it has been licensed for use

Phase IV

Full title

Aztreonam for inhalation for the treatment of acute exacerbations in cystic fibrosis. An open-label, randomised, cross-over pilot study of AZLI plus intravenous Colistin versus standard dual intravenous therapy.

Cystic fibrosis (CF) is an inherited condition that affects multiple systems in the body, in particular the lungs where it is characterised by thick mucous secretions, recurrent chest infections and progressive decline in lung function. Individuals with CF suffer repeated chest infections that often require an admission to hospital to be treated with two antibiotics via a drip. Repeated courses of antibiotics via drip can cause side-effects and damage to other organs. This study aims to investigate whether it is safe and effective to use one inhaled antibiotic and one via a drip, instead of the current standard of practice of two antibiotics via a drip. Participants will receive the two different treatments the next two occasions they need to be admitted to Liverpool Heart & Chest Hospital with a chest infection. On one admission they will receive two IV antibiotics, on the other admission they will receive one IV antibiotic and inhaled aztreonam (known as Cayston®). The order they receive each treatment will be picked at random. Participants will have measurements taken including lung function tests, blood tests, CF quality of life questionnaires, and sputum samples will be sent to the University of Liverpool for advanced analysis of the effect each treatment has on bugs in the lung. It is hoped that this study may help provide more information toward a much needed expansion of therapeutic options available in CF.

Trial Reference Number

91099

Trial type

Medication

Length of participation
the length of time a participant will take part in a trial, from the first to the last appointment

2 exacerbations

Intervention
the name of the treatment or therapy being researched

Aztreonam antiobiotic

Recruitment target
the number of participants who need to be recruited for the trial in the UK

16

Last edited date

20 July 2018

CF sponsor

Liverpool Heart and Chest Hospital NHS Foundation Trust

CF sponsor type

Academic

Who can take part?

Age

18+

Top inclusion criteria
  • 18 - 65 years old Pseudomonas aeruginosa in last 6 months
  • FEV1 25-75%
Top exclusion criteria
  • Growth of Burkholderia Cepacia Complex (BCC) within 2 years
  • Already prescribed regular Cayston Previous organ transplant Documented allergy to beta-lactam antibiotics or IV Colistin

CF centres running this trial

Closed

Liverpool Heart and Chest Hospitals NHS Foundation Trust

Address

Thomas Drive Liverpool Merseyside L14 3PE

Recruitment starts

January 2017

Recruitment ends

December 2017

Contact

Frost, Freddy

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