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PRIVATE

Details

Therapeutic category
the type of treatment or therapy being studied. A therapy could range from a medication addressing a particular characteristic of CF to a device or activity e.g. exercise

Other

Trial status

Closed

Participating Centres
Phase
the different stages involved in the development of a new medication. Phase I focuses on initial safety in people. Phase 2 evaluates safety, correct dose and early signs of whether the medication works. Phase 3 is the stage before medication licensing and looks at safety and medication effectiveness. Phase 4 evaluates longer term use of a medication after it has been licensed for use

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
the number of participants who need to be recruited for the trial in the UK

30

Last edited date

15 July 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.

CF centres running this trial

Closed

Belfast City Hospital

Address

51 Lisburn Road Belfast BT9 7AB

Contact

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