KAFPATH-CF

Details

CTAP badge
Therapeutic approach
Observational
Trial status
Open to recruitment Participating Centres
Trials Tracker ID
TT006611
Last updated
12/04/2022

Full title

KAFPATH-CF: Effects of Kaftrio on lung infection and the wider lung microbiota in cystic fibrosis

Study details

The 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.



In the UK, Kaftrio use is expected to be opened up to children between 6-11 years old with suitable genes from late 2021. Participation of this study will be extended to this age group when this happens.


Phase
Not applicable
Recruitment target
300
CF sponsor type
Academic

Who can take part?

Age range
18+ years
Including people

Adults (≥18 years) that 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).

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CF centres running this trial

Recruiting

Manchester (Adults) - Wythenshawe Hospital

CTAP centre
NHS Trust
Manchester University NHS Foundation Trust
Address
Wythenshawe Hospital
South Moor Road
M23 9LT
Local site investigator
Professor Alex Horsley and Dr Andy Jones
Trial Coordinators
Sarah Sampson
Recruiting

Royal Manchester Children's Hospital (Paediatrics)

CTAP centre
NHS Trust
Manchester University NHS Foundation Trust
Address
Oxford Road
M13 9WL
Local site investigator
Dr Anirban Maitra
Trial Coordinators
Sarah Sampson
Closed

Cardiff - Noah's Ark Children's Hospital for Wales

CTAP centre
NHS Trust
Cardiff and Vale University Health Board
Address
Children and Young Adults Research Unit
Heath Park
CF14 4XW
Local site investigator
Dr Julian Forton
Trial Coordinators
Catherine Joyce
Closed

Cardiff - University Hospital Llandough (Adults)

CTAP centre
NHS Trust
Cardiff and Vale University Health Board
Address
Penland Road
Llandough
CF64 2XX
Local site investigator
Dr Jamie Duckers
Trial Coordinators
Catherine Joyce
Closed

Great Ormond Street Hospital for Children (London)

CTAP centre
NHS Trust
Great Ormond Street Hospital for Children NHS Foundation Trust
Address
Great Ormond Street
WC1N 3JH
Local site investigator
Dr Rossa Brugha
Trial Coordinators
Lucy Holt
Closed

Southampton General Hospital

CTAP centre
NHS Trust
University Hospital Southampton NHS Foundation Trust
Address
Tremona Road
SO16 6YD
Local site investigator
Dr Gary Connet / Dr Julian Legg (Paediatrics) and Dr Thom Daniels (Adults)
Trial Coordinators
Matthew Harvey