PRECISION P3: Finding new ways of detecting and understanding lung infections in CF to help personalise treatment

Full title

The Precision Partners Platform (P3) study: a multi-centre, sample-based study to establish alternatives to sputum culture for detecting lung infections in cystic fibrosis, and to better understand what causes different responses to infections

Study details

The study is looking to find new, reliable and straightforward ways of testing for infections that do not require sputum. Accurate diagnosis of infections is more difficult as improved health, in particular with CFTR modulators, leads to less sputum being coughed up. This study will look at new ways of testing for infections that are acceptable for people with CF or chronic suppurative lung disease (CSLD) in order to detect, monitor and treat lung infections early. 

People with CSLD often suffer with similar infections to people with CF, and so are being invited to take part in the study to make this as inclusive as possible. Samples will also be collected from ‘healthy volunteers’ (people without CF or CSLD) and used for comparison against samples from people with CF or CSLD to further improve our understanding of how these infections can be detected and how they behave.

This study also hopes to better understand what causes the different responses people have to infections, to see if there are new ways treatments can be made targeted.

What the study involves: 

To take part, people will be asked to provide a range of samples. Types of samples requested might differ depending on the centre. Providing samples is completely voluntary and people can choose to not provide some of them if they feel they are not acceptable to them. In the case of younger children, parents and the research team will help determine what samples can be provided. 

Here is a list of samples you may be asked to provide: 

• spontaneous sputum (or induced sputum if no spontaneous sputum or bronchoalveaolar lavage is available)
• bronchoalveolar lavage (only if already being given as part of a scheduled / inpatient visit)
• endobronchial biopsy (only if already being given as part of a scheduled / inpatient visit)
• nasal secretions
• saliva
• throat swabs
• cough swabs
• gargles
• breath
• exhaled breath condensate
• skin secretions
• urine
• blood (for children only if already being given as part of your a scheduled / inpatient visit)
• stool

Duration of study visit will depend on the number of samples taken. If all are collected it is expected sampling will take up to 2.5 hours. 

Samples are planned to be taken while people with CF or CSLD are already at the hospital, either for a scheduled outpatient appointment or during an inpatient stay. People without CF or CSLD, and people with CF or CSLD who volunteer to attend outside of these visits, will be reimbursed for travel costs. 

Study follow-up will last for up to 5 years. Follow-up visits and repeat samples will be done at times people are already in hospital. These follow-up visits will be opportunistic and flexible, rather than needing to be done at regular intervals throughout the year. During follow-up visits, people can choose to provide different sample types if they wish.

The study is available at multiple centres across the UK with the aim of recruiting a larger, more diverse and representative group of people. 

This study is part of the PRECISION CF Innovation Hub (PolymicRobial infECtions: bIomarkerS, dIagnOstics & mechaNisms). The Precision CF Innovation Hub aims to improve the detection, diagnosis and treatment of lung infections in people with CF. This is one of four Innovation Hubs funded by the Trust and LifeArc.

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