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CF START

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

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

The cystic fibrosis (CF) anti-staphylococcal antibiotic prophylaxis trial (CF START); a randomised registry trial to assess the safety and efficacy of flucloxacillin as a longterm prophylaxis agent for infants with CF.

CF START is a national UK trial that will determine the safest and most effective antibiotic strategy for infants diagnosed with cystic fibrosis (CF). 480 CF infants will be randomly allocated either flucloxacillin prophylaxis (the current UK standard of care) or antibiotics given in a more targeted manner. The primary outcome will be the age at first growth of Pseudomonas aeruginosa from a respiratory culture (an important safety measure for families). All outcomes will be recorded on a national CF Registry, including a number of secondary outcomes assessing effectiveness and safety. Finally at 40-48 months, a measure of respiratory function will be undertaken in a central laboratory, which will provide a clearer indication of the effectiveness of these two strategies.

Trial Reference Number

86464

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

48 months

Intervention
the name of the treatment or therapy being researched

Flucloxacillin antiobiotic

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

480

Last edited date

27 April 2020

CF sponsor

Alder Hey Children's NHS Foundation Trust

CF sponsor type

Academic

Who can take part?

Age

0 - 12

Top inclusion criteria
  • Two CF-causing mutations are identified OROne or no CF- causing mutations identified, sweat chloride test result > 59 mmol/L
  • Age 70 days or less
  • Consent for inclusion on the national UK CF Registry
  • Consent for inclusion in the CF START trial
Top exclusion criteria
  • An inconclusive diagnosis after newborn screening (NBS)
  • Previous growth of Pseudomonas aeruginosa from respiratory culture

CF centres running this trial

Recruiting

Brighton and Sussex University Hospitals NHS Trust

Address

Sussex Cancer Centre Royal Sussex County Hospital Eastern Road Brighton BN2 5BE

Recruitment starts

May 2018

Recruitment ends

July 2025

Contact

Seddon, Paul

Get in touch

Recruiting

King's College Hospital NHS Foundation Trust

Address

Denmark Hill London Greater London SE5 9RS

Recruitment starts

November 2017

Recruitment ends

June 2025

Contact

Bossley, Cara

Get in touch

Recruiting

King's Mill Hospital

Address

Mansfield Rd Sutton-in-Ashfield Nottinghamshire NG17 4JL

Recruitment starts

May 2018

Recruitment ends

January 2022

Contact

Yanney, Michael

Get in touch

Recruiting

Sheffield Children's NHS Foundation Trust

Address

Western Bank Sheffield South Yorkshire S10 2TH

Recruitment starts

July 2017

Recruitment ends

July 2021

Contact

West, Noreen

Get in touch
Show all participating centres