Bacterial Gene Profiling to Predict Antibiotic Resistance During Cystic Fibrosis Pulmonary Exacerbations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Change in lung function
研究概览
简要总结
Pulmonary exacerbations (PEx) are key events that lead to a decline in health status among CF patients, with many never recovering to baseline health. With the advancement of new CFTR modulators and other therapies increasing the lifespan of those living with CF, it will become increasingly important to have better strategies to manage PEx in order to have better outcomes following treatment. PEx treatment decisions will need to take into consideration the increasing frequency of antimicrobial resistance bacteria and the need to treat multiple types of bacteria at once. The purpose of this study is to analyze sputum samples from CF subjects at the time of PEx in order to identify markers of antimicrobial resistant bacteria and see how those relate to treatment responses. CF patients will be recruited from patients followed by the Adult CF Program at National Jewish Health. Within 48 hours of admission to the hospital for treatment of a PEx, subjects will be enrolled and sputum will be collected. The sputum will be processed and analyzed for the presence of antimicrobial resistant bacteria. These results will be compared to clinical data, such as spirometry and frequency of hospitalizations.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •CF patients 18 years or older who are hospitalized for IV treatment of an acute PEx
- •Chronically infected with Pseudomonas aeruginosa and/or Staphylococcus aureus
- •Can produce sputum
- •Can provide written consent
- •Willing to comply with study procedure
排除标准
- •Subjects who are not colonized with Pseudomonas aeruginosa and/or Staphylococcus aureus
- •The presence of a condition or abnormality that, in the opinion of the Principal Investigator, would compromise the safety of the patient or the quality of the data
结局指标
主要结局
Change in lung function
时间窗: At initiation of IV antibiotic treatment and after one week of IV antibiotic treatment
Change in lung function as measured by FEV1, % predicted.
Targeted amplicon sequencing of sputum
时间窗: Within 48 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation
Results from CF specific amplicon panel; this may include number and identity of bacterial species, presence or absence of AMR genes, frequencies of strain types, and AMR genes per total bacteria
Sputum microbiology
时间窗: Within 48 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation
Traditional sputum microbiology results; this may include quantitative culture data for each pathogen, antimicrobial susceptibilities, and minimum inhibitory concentration (MIC)
次要结局
- Antimicrobial regimens(Throughout course of hospitalization, on average 14 days)
- Changes in hospitalizations(12 months prior to enrollment to 12 months after enrollment)