PRIVATE

Details

Therapeutic category
Other
Trial status
Completed Participating Centres
Phase
Not Applicable

Full title

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

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 aims to assess if multi-dimensional measurements taken during treatment correspond with later treatment response. This may allow us to personalise treatment more effectively in the future and to better understand how individuals respond to treatment. As yet there is no model for predicting how patients with CF will respond to IV antibiotic treatment- other than clinical judgement and lung function response.This is due to lack of robust measures to identify clinical response at the time of treatment and safely predict later clinical outcomes. The heterogeneity of the 21st Century CF population means a multi-dimensional composite measure is needed. This study has therefore been designed to provide an overall picture of people's response including clinical, biochemical and patient related outcome measures. 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.
Trial Reference Number
84648
Trial type
Non-medication
Recruitment target
30
Last edited date
15/07/2019
CF sponsor
Belfast Health and Social Care Trust
CF sponsor type
Academic

Who can take part?

Age
18+
Top inclusion criteria
  • Patients attending the Belfast Regional Adult CF Centre with a confirmed diagnosis of CF by sweat test or genotype.
  • Confirmed Pulmonary Exacerbation requiring treatment with intravenous antibiotics using defined criteria.
Top exclusion criteria
  • Previous recipient of a lung or other solid organ transplant.
  • Current enrolment in other investigational medicinal product randomised trial.
  • Admission for reasons other than pulmonary exacerbation of CF.

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