PRIVATE

• Research type

  Research Study

• Full title

  Parameters to assess Response to Intra-Venous Antibiotic Treatment for pulmonary Exacerbations in Cystic Fibrosis (PRIVATE)

• IRAS ID

  210802

• Contact name

  Damian Downey

• Contact email

  d.downey@qub.ac.uk

• Sponsor organisation

  Belfast Health and Social Care Trust

• Duration of Study in the UK

  1 years, 9 months, 30 days

• Research summary

  Cystic fibrosis (CF) is a multi-system disease characterized by viscid secretions in multiple organ systems. Lung infection and damage account for most of the disease burden. Acute changes in respiratory signs and symptoms termed pulmonary exacerbations require treatment with intravenous antibiotics and hospital admission. These episodes cause substantial disruption to people’s lives and impact on lung function, quality of life and lifespan. Current treatment regimes require improvement but further study is needed to identify who might benefit from a different approach.

  This observational study is designed to fit into routine clinical care as much as possible. It aims to assess if measurements taken during the first 5 days of an exacerbation can help assess how people respond to a full course of treatment and their later clinical course.
  
  Current measures including blood tests and lung function do not always reflect how people feel. Using multi-dimensional assessment we hope the measures assessed in this study will give a better picture of how people feel and how they respond to treatment. Assessment will include clinical (Vital Signs, Lung Function), microbiological (culture and non-culture based), Biochemical (CRP and other biomarkers) and patient related (Physical activity levels, Symptoms) parameters. We will use routine clinical samples (blood and sputum), questionnaires and a wearable activity monitor (Fitbit) to measure these parameters. These will then be correlated with clinical outcomes in the short (end of treatment), medium (1-3 months) and longer term (12 months).

  The study will be undertaken at the Belfast Regional Adult CF Centre. Any person with CF being admitted for intravenous treatment of a Pulmonary Exacerbation not enrolled in another randomised trial will be eligible. Measurements will be taken on admission, day 5 and the end of treatment. Further follow up will be through routine clinic visits and medical notes.

• REC name

  HSC REC A

• REC reference

  16/NI/0190

• Date of REC Opinion

  30 Sep 2016

• REC opinion

  Favourable Opinion