CF START

Details

Therapeutic category
Anti-Infective
Trial status
Open to recruitment Participating Centres
Phase
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
48 months
Intervention
Flucloxacillin antiobiotic
Recruitment target
480
Last edited date
30/09/2020
CF sponsor
Alder Hey Children's NHS Foundation Trust
CF sponsor type
Academic

Who can take part?

Age
70 days or less
Top inclusion criteria
  • Two CF-causing mutations are identified OR one 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

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