NCT03947957进行中（未招募）不适用
Microbial Biomarkers of EArly Pseudomonas Aeruginosa Colonization in CHildren With Cystic Fibrosis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 70
- 试验地点
- 11
- 主要终点
- Presence of P. aeruginosa in bacterial sputum cultures collected at 36 months of age
研究概览
简要总结
The objective of this study is to evaluate the predictive nature of the biomarker Porphyromonas catoniae measured at the age of 12 months in the occurrence of colonization with Pseudomonas aeruginosa at 36 months of age in children with cystic fibrosis.
详细描述
This is a multicentric study in 3 phases:
- Pre-inclusion: at the first visit to the CRCM (support for a positive screening confirmed by sweat test and genotyping CFTR)
- Inclusion: possible between the 2nd visit to the CRCM (about 2 months old) and the 6th month
- Follow-up: up to 36 months old. The pace of visits will be based on the usual follow-up rate of CF infants
The clinical data as well as samples (expectorations, stools) will be collected on a monthly basis up to 6 months old and then every 2 months until one year old and finally quarterly until 3 years old.
- Tracheo-bronchial secretions will be collected at the CRCM
- Stools samples will be carried out by the parents prior to consultation with the CRCM
- A blood collection will be carried out annually in an annual report.
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
- 2 Months 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants aged 6 months maximum at inclusion with a confirmed diagnosis of cystic fibrosis in its classical form (positive sweat test and/or two mutations of the CFTR gene from class I to III) -Children free from any antecedent of colonization to P. aeruginosa at the time of inclusion (certified by the microbiological history supplemented by a molecular test by qPCR according to the diagram of Le gal et al., 2013)---
- •Affiliation to the social security system
- •Consent signed by the holders of parental authority or the sole parent holding parental authority / and "oral" agreement of the second holder
排除标准
- •Severe acute illness (other than cystic fibrosis) ongoing, or requiring surgery
- •Children unable to undergo the tests required by the protocol
- •Children whose parent(s) is/are minors
- •Children whose legal guardians do not have sufficient command of the French language
- •Children under exclusive parenteral nutrition
- •Refusal to participate in the study
研究组 & 干预措施
collection of expectoration, stools and blood
Other
干预措施: collection of expectoration, stools and blood (Diagnostic Test)
结局指标
主要结局
Presence of P. aeruginosa in bacterial sputum cultures collected at 36 months of age
时间窗: 36 months
positive or negative
次要结局
- Absolute amount of P. aeruginosa at different sampling times.(36 months)
- Level of dysbiosis(36 months)
- Absolute amount of P. catoniae in respiratory secretions at different sampling times and Delta between 12, 24 and 36 months.(36 months)
- Absolute amount of P. catoniae in stool at different sampling times and Delta between 12, 24 and 36 months.(36 months)
- Number, diversity, and quality of antibiotic resistance genes(36 Months)
- Levels of blood metabolites(36 Months)
- Pulmonary concentration of inflammatory markers(36 months)
- Constitutional SNPs(36 Months)
- Breastfeeding at each visit(36 Months)
- Dietary diversification at each visit(36 Months)
- Treatments received at each visit(36 Months)
研究者
研究点 (11)
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