Viral Pathogenesis of Early Cystic Fibrosis Lung Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 4
- 主要终点
- Viral infection
研究概览
简要总结
The purpose of this study is to test the hypothesis that early viral infections alter the bacterial flora and inflammatory profile in the airway and accelerate progression of pulmonary disease in infants with cystic fibrosis.
详细描述
The proposed study is a unique international collaboration between three large CF research centers. This proposal will determine the impact of early respiratory viral infections on bacterial flora and inflammatory profiles in the CF airway as well as the impact of these pathogens on clinical, physiologic and structural markers of disease.The proposed study is designed to follow infants diagnosed with CF through newborn screening to determine the effect of viral infections on the lower airway microbiome, clinical symptoms, pulmonary function and structural changes during the first year of life. The proposed study will measure lower airway inflammation and infection using BAL, oral swabs, and nasal swabs; outcomes will be assessed through infant lung function testing, computerized tomography scans of the chest, and pulmonary exacerbation rate.
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
- 2 Months 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of CF by newborn screening, at least one clinical feature of CF, and documented sweat chloride greater than 60 mEq/L by quantitative pilocarpine iontophoresis or compatible genotype with two identifiable mutant CFTR alleles.
- •Less than 4 months of age at Screening Visit
- •Ability to comply with study visits and study procedures as judged by site investigator.
排除标准
- •Intercurrent respiratory illness, defined as increase in cough, wheezing, or respiratory rate with onset 14 days before iPFT-bronchoscopy visit.
- •Measured hemoglobin oxygen saturation less than 95% during the iPFT-bronchoscopy visit.
- •History of adverse reaction to sedation.
- •Clinically significant upper airway obstruction as determined by the site investigator.
- •Severe gastroesophageal reflux, defined as persistent frequent emesis despite therapy.
- •Major organ dysfunction, not including pancreatic dysfunction.
- •Physical findings that would compromise the safety of the subject or the quality of the study data as determined by site investigator.
结局指标
主要结局
Viral infection
时间窗: 12 months
To determine the effect(s) of viral infections on the evolution of endobronchial bacterial infection and inflammation in CF infants.
次要结局
- Forced Expiratory Volume(12 months)
- Pulmonary exacerbation rate(12 Months)
研究者
Stephanie D. Davis
MD, Section Director of Pediatric Pulmonology, Allergy and Sleep Medicine
Indiana University