NCT05584982已完成不适用
Open-label, Single-arm, Investigator-Initiated Clinical Study to Investigate the Performance of the AtbFinder® Diagnostic Test System for Selection of Antibiotic Therapy in Persons With Cystic Fibrosis
TGV-Dx0 个研究点目标入组 35 人开始时间: 2016年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 主要终点
- Time to an exacerbation (in months)
研究概览
简要总结
This prospective case-control study was planned to evaluate the efficacy of antibiotic therapy selected with the AtbFinder® in persons with cystic fibrosis.
详细描述
This pilot study entitled "Clinical Performance of the AtbFinder® diagnostic test system for selection of antibiotic therapy in persons with cystic fibrosis " was designed to demonstrate the clinical performance of antibiotics selected with the AtbFinder® for the treatment of lung infections in persons with cystic fibrosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of cystic fibrosis based on sweat chloride levels = or > 60, or genetic testing showing 2 pathogenic mutations.
- •Ability to provide a clinical sample (expectorated sputum, throat culture or bronchoalveolar lavage) prior to the start of the antibiotic treatment.
- •Prior treatment of a pulmonary exacerbation with systemic antibiotics in the preceding year.
排除标准
- •Inability to meet any of the above inclusion criteria.
- •Systemic therapy with an antibiotic or corticosteroids in the 3 weeks preceding enrollment in the study, except those on chronic inhaled antibiotics.
- •Primary or secondary (drug- or condition-induced) immune compromise.
- •Creatinine > 2 x upper limit of normal for age.
- •Previous participation in this study in the prior 28 days.
结局指标
主要结局
Time to an exacerbation (in months)
时间窗: Time Frame: up to 24 months
次要结局
- Changes in bacterial load of isolated organisms (the number of colony forming units per 1 ml of sputum) from baseline to end of treatment(Time Frame: up to 24 months)
- Evaluate changes in forced expiratory volume from baseline to end of study(Time Frame: up to 24 months)
- Changes in blood white blood cell count (10*9 mg/L)(Time Frame: up to 24 months)
- Changes in blood C-reactive protein (in mg/L)(Time Frame: up to 24 months)
- Changes in body mass index calculated as weight (in kilograms) divided by height squared (m2).(Time Frame: up to 24 months)
- Changes in weight (in kilograms)(Time Frame: up to 24 months)
- Changes in Pseudomonas aeruginosa load (the number of colony forming units per 1 ml of sputum) from baseline to end of treatment(Time Frame: up to 24 months)
研究者
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