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CF START

  • Research type

    Research Study

  • 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.

  • IRAS ID

    211995

  • Contact name

    Kevin Southern

  • Contact email

    k.w.southern@liverpool.ac.uk

  • Sponsor organisation

    Alder Hey Children's NHS Foundation Trust

  • Eudract number

    2016-002578-11

  • Duration of Study in the UK

    8 years, 11 months, 31 days

  • Research summary

    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.

  • REC name

    North West - Liverpool Central Research Ethics Committee

  • REC reference

    16/NW/0629

  • Date of REC Opinion

    16 Sep 2016

  • REC opinion

    Further Information Favourable Opinion