Parameters to Assess Response to Intra-Venous Antibiotic Treatment for Pulmonary Exacerbations in Cystic Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Forced Expiratory Volume in 1 second (FEV1)
研究概览
简要总结
Cystic fibrosis (CF) is a multisystem 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 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.
详细描述
Pulmonary Exacerbations in CF require treatment with intravenous (IV) antibiotics and hospital admission for between 10-21 days. These episodes cause substantial disruption to people's lives and impact on lung function, quality of life and lifespan.Robust evidence to support current treatment approaches is lacking with awareness that current regimes could be optimised.
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients attending the adult service with a confirmed diagnosis of CF by sweat test or genotype
- •Able to provide written informed consent
- •Able to understand and comply with protocol requirements and instructions
- •Confirmed Pulmonary Exacerbation requiring treatment with intravenous antibiotics using defined criteria (Physician and patient agreed need for admission for intravenous antibiotic treatment)
排除标准
- •Previous recipient of a lung or other solid organ transplant
- •Inability to complete questionnaires
- •Current enrolment in other investigational medicinal product randomised trial
- •Admission for reasons other than pulmonary exacerbation of CF
结局指标
主要结局
Forced Expiratory Volume in 1 second (FEV1)
时间窗: Change in lung function between baseline and day 0, Day 5 and Day 14 of treatment
Lung function Measure
次要结局
- Sleep parameters measured by consumable wearable device(Change between Day 0, day 5 and day 14 of treatment)
- Time to next exacerbation(Time to next course of intravenous antibiotics within 12 month follow up period (study end))
- Change in Respiratory Symptoms(Change between Day 0, day 5 and day 14 of treatment)
- Change in sputum inflammatory markers(Change between Day 0, day 5 and day 14 of treatment)
- Change in serum inflammatory marker (C-Reactive Protein)(Change between Day 0, day 5 and day 14 of treatment)
- Change in microbiological growth measured by culture(Change between Day 0, day 5 and day 14 of treatment)
- Change in 24 hour sputum volume(Change between Day 0, day 5 and day 14 of treatment)
- Treatment Failure defined by need for further IV antibiotic treatment within 30 days(Need for a further course of IV antibiotics within 30 days of treatment completion)
- Physical activity levels (step count, distance walked, Lightly active minutes, Moderate velocity physical activity (MVPA) and Exercise)(Change between Day 0, day 5 and day 14 of treatment)
- Change in microbiological community composition measured by microbiota analysis(Change between Day 0, day 5 and day 14 of treatment)