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AZTEC-CF - Gilead IN-UK-205-4065

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

Open to recruitment

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.

This study’s primary objective is to investigate whether there is immediate clinical benefit in the use of Cayston® in acute exacerbations of CF. Repeated courses of antibiotics via a drip (also known as intravenous or IV antibiotics) can cause long-term side effects including deafness and chronic kidney disease. It is therefore important to explore newer approaches for treating chest infections in CF. Nebulised antibiotics provide an opportunity to deliver antibiotics straight to the lungs with significantly less of the drug being absorbed into the blood stream. This means that potential side effects and long-term damage to other organs are minimised. Furthermore nebulised antibiotics are generally well tolerated, less invasive and require less time to administer. AZTEC-CF aims to evaluate whether inhaled antibiotic treatment is beneficial in the treatment of acute chest infections

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 or standard care

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

16

Last edited date

31 August 2017

Sponsor

Liverpool Heart and Chest Hospital NHS Foundation Trust

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

Get in touch