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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

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

Not Applicable

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 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

Prophylaxis flucloxacillin or targeted antibiotics

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

480

Last edited date

29 August 2017

Sponsor

Alder Hey Children's NHS Foundation Trust

Sponsor type

Academic

Who can take part?

Age

0 - 12

Top inclusion criteria
  • Age 70 days or less
  • A confirmed diagnosis of cystic fibrosis through one of the following three routes:
  • Two CF-causing mutations identified
  • One, or no CF- causing mutations identified and a sweat chloride test result greater than 59 mmol/L
  • Two CFTR mutations (not known CF-causing mutations) and a sweat chloride test result greater than 29 mmol/L
  • Consent for inclusion on the national UK CF Registry
Top exclusion criteria
  • An inconclusive diagnosis after newborn screening (NBS)
  • A condition (non-CF) that, in the opinion of the recruiting investigator will impact on the long-term management and outcome of a participant with CF
  • Previous growth of Pseudomonas aeruginosa from respiratory culture
  • Infants with a history of hypersensitivity to β-lactam antibiotics (e.g. penicillins) or excipients
  • Infants with a history of flucloxacillin associated jaundice/hepatic dysfunction

CF centres running this trial

Recruiting

Alder Hey Children's NHS Foundation Trust

Address

Alder Hey Hospital Eaton Road West Derby Liverpool Merseyside L12 2AP

Recruitment starts

December 2016

Recruitment ends

March 2020

Contact

Southern, Kevin

Get in touch

Recruiting

Arrowe Park Hospital

Address

Arrowe Park Road Upton Wirral Merseyside CH49 5PE

Recruitment starts

March 2017

Recruitment ends

January 2020

Contact

Lacy, David

Get in touch

Recruiting

Birmingham Children's Hospital NHS Foundation Trust

Address

Steelhouse Lane Birmingham West Midlands B4 6NH

Recruitment starts

March 2017

Recruitment ends

January 2020

Contact

Desai, Maya

Get in touch

Recruiting

Blackpool Victoria Hospital

Address

Blackpool Victoria Hospital Whiney Heys Road Blackpool FY3 8NR

Recruitment starts

August 2017

Recruitment ends

January 2020

Contact

Rowlands, Alan

Get in touch
Show all participating centres