The Cystic Fibrosis Trust and the National Institute for Health Research have announced CF START, a UK-wide clinical trial to assess whether prescribing antibiotics for infants with cystic fibrosis as a preventative measure reduces infection from bugs, or risks exposing children to earlier infection from harmful bacteria such as Pseudomonas.
Half of the participants (who must be under 70 days old at the time of enrolment) will be observed over four years following the established UK practice of prescribing a long-term antibiotic, usually Flucloxacillin, as a ‘prevent and treat’ approach to combatting bacterial infection. The other half will be put on a ‘detect and treat’ programme, where antibiotics are only given if harmful bacteria are found.
The team, led by Professor Kevin Southern at Alder Hey Children’s Hospital, will also carefully observe how much treatment the infants need and whether they require extra antibiotics. At the end of the study, when children are old enough to be tested, lung health will be measured.
CF START will use the UK Cystic Fibrosis Registry to monitor results, making it the first randomised Registry trial in the UK to involve children. The Registry, a database sponsored and managed by the Cystic Fibrosis Trust, holds health data for 99% of consenting people living with the condition in the UK.
Professor Southern explains: “CF START is taking an innovative approach to clinical trials that will benefit patients, researchers, and the wider NHS, potentially resulting in a change to clinical practice on a global level. Results on the Registry will record how these infants are progressing, which means families in CF START will not have any additional burden aside from their usual clinic visits, and they will not need to make separate trial visits to the hospital.”
Speaking from experience, Zoe Elliott is keen that parents understand the importance of supporting trials: “I am the mum of six-year-old twins, who, despite having cystic fibrosis, are ‘healthy’. It is thanks to the research that has and is happening that this is the case.
“Trials don’t happen if people don’t take part and so the twins are put forward for trials at every opportunity. It is my way of saying thanks to those who participated in trials that they now benefit from and to pay it forward.”
Recruitment for CF START will begin in autumn 2016.