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

Record ID 32016001089
Authors' objectives: The aim of the CF START study is to determine the safest and most effective antibiotic strategy for infants diagnosed with cystic fibrosis. Cystic fibrosis (or CF) is an inherited genetic condition. Infants with CF in the UK are most often diagnosed following a positive newborn screening test. They may appear quite well initially but quickly develop significant chest infections, which if untreated will cause lung damage and early death. For many years, physicians in the UK have prescribed children with CF long-term antibiotics that they take every day. Most often this is an antibiotic called flucloxacillin. The aim of this strategy is to prevent lung infection with Staphylococcus, which is known to be a common bug causing infection for people with CF. Physicians in other countries have been more reticent to use this approach and have tended to only prescribe antibiotics when the infant has a cough or grows a bug from a cough (or throat) swab. The reason they use this more targeted approach is that they are concerned that use of long-term antibiotics may predispose the child to earlier infections with other more resistant bugs, in particular Pseudomonas. The UK newborn screening programme has thrown into perspective the issue of how to best treat these infants who appear well at diagnosis. In addition, results from the national registry suggest that children with CF who are not on flucloxacillin may have less infection with Pseudomonas. It is apparent therefore that this is an opportune time to undertake a study in the UK to determine the safest and most effective approach for these children. For the CF START study, 440 infants with a clear diagnosis of CF will be randomly allocated to receive either flucloxacillin given twice every day (called Prevent and Treat ) or antibiotics given in a more targeted manner ( Detect and Treat ). We will record the age of the infant when they first grow Pseudomonas from a cough swab, as well as other bugs. We shall also record how many extra courses of antibiotics are required and the number of hospital admissions. These outcomes will be recorded on the national Registry database, as part of routine care, which means the families will not be required to make extra clinic visits. Finally, once the child is over 40 months of age, the family will be invited to a national respiratory laboratory for a test of lung function, the lung clearance index. This part of the study will be voluntary for the families and will provide important information on respiratory condition of children in the study.
Project Status: Ongoing
Anticipated Publish Date: 2021
English language abstract: An English language summary is available
Publication Type: Not Assigned
Country: England, United Kingdom
MeSH Terms
  • Respiratory Tract Infections
  • Anti-Bacterial Agents
  • Antibiotic Prophylaxis
  • Cystic Fibrosis
  • Floxacillin
  • Infant
  • Infant, Newborn, Diseases
  • Staphylococcal Infections
Organisation Name: NIHR Health Technology Assessment programme
Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK
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