Control and Prevention of Respiratory Infections in Cystic Fibrosis Patients: an Evaluation of the Emission Distance of P. Aeruginosa From the Respiratory Tract of Infected Persons Through Coughing and Conversation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Prevalence of surface samples positive for PA
研究概览
简要总结
It is well known that an association exists between the acquisition of some respiratory pathogens and prognosis of CF people. About 57 % of patients has a lung infection due to P.aeruginosa (PA). Transmission of PA between CF patients is possible and several prevention measures are recommended. Among these measures, all international guidelines recommend that CF people maintain a minimum distance of 1 meter between them. However, this recommendation is not supported by specific studies and scientific evidence. In other words, the investigators don't know if this measure is sufficient or excessive, as it is based only on a theoretical rationale.
This study aims at measuring experimentally the distance that can be reached by PA emitted from airways of colonized CF patients during cough and during conversation.
To this purpose, the investigators will evacuate the presence of PA on surfaces placed at 4 different distances from patients, through the collection of 8 swabs, 4 of which following cough and 4 following conversation. Swabs will be collected on sterile surfaces comprised between tra 0 - 0,5 mt; 0,5 -1,00 mt.; 1,00 - 1,5 mt and 1.5-2 mt.
All the PA-positive CF patients of the CF Centre of Tuscany aged 14 or more will be recruited.
详细描述
Background
Cystic Fibrosis (CF) represents the most frequent genetic disorder with autosomal recessive transmission having a negative prognosis in Caucasian populations, with an incidence of about 1 in 3000. CF is a multisystemic disease involving the exocrine functions, in particular, of the respiratory tract and the gastroenteric system. The mutated gene causes an alteration in the transportation of chloride and sodium that leads to the production of denser bronchial secretion, favouring the onset of chronic respiratory infections, inflammations and respiratory insufficiency. Indeed, pulmonary infections are one of the primary characteristics, as well as the main cause of morbidity and mortality in CF.
There is an association between the acquisition of some respiratory pathogens (mainly B. cepacia complex [BCC] and P. aeruginosa [PA]) and the worsening of the parameters of respiratory function and a lower survival rate.
Recent epidemiological data show that 57.3% of CF patients have a pulmonary infection caused by PA.
Therefore, to prevent the clinical consequences deriving from chronic colonization of PA, avoiding contact with the infected patient when possible can be of fundamental importance.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 14 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of CF
- •Age 14 or older.
- •PA infection documented by the most recent expectorate culture available, no more than 3 months old.
排除标准
- 未提供
结局指标
主要结局
Prevalence of surface samples positive for PA
时间窗: six months
次要结局
未报告次要终点
研究者
Filippo Festini
Associate Professor
University of Florence