KAFPATH-CF: Investigating the effects of Kaftrio on lung infection
Details
- Therapeutic approach
- Observational
- Trial status
- Recruitment complete Participating Centres
- Trials Tracker ID
- TT006611
- Last updated
- 12/04/2022
KAFPATH-CF: Effects of Kaftrio on lung infection and the wider lung microbiota in cystic fibrosis
Study detailsThe new medicine Kaftrio is now becoming available from the NHS to people living with cystic fibrosis (CF) with suitable genes. In clinical trials, Kaftrio has been shown to make breathing tests better, helping those who take Kaftrio breathe more easily. This improves their overall quality of life.
Repeated lung infections cause the main problems in CF. We don’t yet know how Kaftrio might change these lung infections, and how this might change the relationship between ‘good’ and ‘bad’ germs in the lungs.
The main idea of this study is to understand how Kaftrio might change lung infections, and how it might change how the ‘good’ and ‘bad’ germs live and work together (‘microbiome’) in the lungs. We hope to find this out by collecting a cough swab or sputum sample before children start Kaftrio, collecting a sample soon after they start to take the medicine and cough up more mucus (‘purge phase’), and collecting follow up samples after they have been taking Kaftrio for around 6 weeks and then at 6 months.
- Phase
- Not applicable
- Recruitment target
- 300
- CF sponsor type
- Academic
Who can take part?
- Age range
- 2 - 5 years
- Including people
Children (aged 2-5 years old) that are Homozygous F508del genotype or compound heterozygous F508del – minimal function genotype.
Capacity to consent, or to understand the requirements of the study where parental consent is needed.
Confirmed diagnosis of CF, either by sweat tests or genetic testing.
- Excluding people
Patients with suspected COVID-19 infection.
Significant other comorbidity that can influence respiratory sample quality or results (i.e. active cancer).