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临床试验/NCT04024423
NCT04024423已完成不适用

Healthcare-associated Links in Transmission of Nontuberculous Mycobacteria Among Patients With Cystic Fibrosis

National Jewish Health1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Number of cystic fibrosis participants with NTM isolates in related clusters and receiving care in the same Cystic Fibrosis Care Center as assessed by whole genome sequencing

研究概览

简要总结

Sources of NTM infection and modes of transmission among CF patients are poorly understood. Healthcare-associated transmission of NTM among CF patients has been suspected and is of growing concern for CF Centers. There is a need for a systematic evidence-based approach to investigating potential episodes of healthcare-associated transmission. Clusters of highly similar strains of NTM in CF patients cared for at the same CF Center may arise from healthcare sources including patient-to-patient transmission and/or acquisition from water sources within a healthcare setting. The primary objective of the study is to facilitate a standardized process by which CF Centers may perform data abstraction on patients identified with highly similar NTM isolates and determine if clustered NTM strains are related to strains isolated from healthcare setting water biofilm sources. HALT NTM is available to the entire CF Foundation Care Network, under a collaborative agreement, to initiate a standardized, independent, confidential, internal NTM outbreak investigation. Patients that are identified by whole genome sequencing as having highly similar NTM strains and receiving care in the same CF Care Center are eligible. The study's primary endpoint is to identify potential modes and sources of healthcare-associated acquisition of CF NTM, thereby revealing risk factors for NTM acquisition.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Participants with cystic fibrosis and respiratory NTM growth on one or more occasions

排除标准

  • Participants without cystic fibrosis
  • Participants without pulmonary NTM growth

结局指标

主要结局

Number of cystic fibrosis participants with NTM isolates in related clusters and receiving care in the same Cystic Fibrosis Care Center as assessed by whole genome sequencing

时间窗: Three years

Retrospective epidemiologic study

Number of cystic fibrosis participants with NTM isolates matching environmental isolates from the participant's Cystic Fibrosis Care Center as assessed by whole genome sequencing

时间窗: Three years

Retrospective epidemiologic study

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jane Gross

Assistant Professor

National Jewish Health

研究点 (1)

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