Department of Pediatrics, National Jewish Health, Denver, CO, United States of America.
Department of Medicine, National Jewish Health, Denver, CO, United States of America.
PLoS One. 2021 Dec 20;16(12):e0261628. doi: 10.1371/journal.pone.0261628. eCollection 2021.
Healthcare-associated transmission of nontuberculous mycobacteria (NTM) among people with cystic fibrosis (pwCF) has been reported and is of increasing concern. No standardized epidemiologic investigation tool has been published for healthcare-associated NTM outbreak investigations. This report describes the design of an ongoing observational study to standardize the approach to NTM outbreak investigation among pwCF.
This is a parallel multi-site study of pwCF within a single Center who have respiratory NTM isolates identified as being highly-similar. Participants have a history of positive airway cultures for NTM, receive care within a single Center, and have been identified as part of a possible outbreak based on genomic analysis of NTM isolates. Participants are enrolled in the study over a 3-year period. Primary endpoints are identification of a shared healthcare-associated encounter(s) among patients in a Center and identification of environmental isolates that are genetically highly-similar to respiratory isolates recovered from pwCF. Secondary endpoints include characterization of potential transmission modes and settings, as well as incidence and prevalence of healthcare-associated environmental NTM species/subspecies by geographical region.
We hypothesize that genetically highly-similar strains of NTM among pwCF cared for at the same Center may arise from healthcare sources including patient-to-patient transmission and/or acquisition from environmental sources. This novel study design will establish a standardized, evidence-based epidemiologic investigation tool for healthcare-associated NTM outbreak investigation within CF Care Centers, will broaden the scope of independent outbreak investigations and demonstrate the frequency and nature of healthcare-associated NTM transmission in CF Care Centers nationwide. Furthermore, it will provide valuable insights into modeling risk factors associated with healthcare-associated NTM transmission and better inform future infection prevention and control guidelines. This study will systematically characterize clinically-relevant NTM isolates of CF healthcare environmental dust and water biofilms and set the stage to describe the most common environmental sources within the healthcare setting harboring clinically-relevant NTM isolates.
ClinicalTrials.gov NCT04024423. Date of registry July 18, 2019.
已报道囊性纤维化（CF）患者之间存在非结核分枝杆菌（NTM）的医源性传播，且这一问题的关注度日益增加。目前尚无针对医源性 NTM 暴发调查的标准化流行病学调查工具。本报告描述了一项正在进行的观察性研究，旨在为 CF 患者中 NTM 暴发调查制定标准化方法。
这是一项在单个中心内 CF 患者的平行多站点研究，这些患者的呼吸道 NTM 分离株具有高度相似性。参与者有 NTM 气道培养阳性史，在单个中心内接受治疗，并根据 NTM 分离株的基因组分析被确定为可能暴发的一部分。参与者在 3 年内入组本研究。主要终点是确定中心内患者之间是否存在共同的医源性接触，以及确定与从 CF 患者中分离出的呼吸道分离株具有高度遗传相似性的环境分离株。次要终点包括对潜在传播模式和环境的特征描述，以及按地理位置确定医源性环境 NTM 种/亚种的发生率和患病率。
我们假设在同一中心接受治疗的 CF 患者中具有高度遗传相似性的 NTM 菌株可能来自医疗来源，包括患者之间的传播和/或从环境来源获得。这种新的研究设计将为 CF 护理中心内医源性 NTM 暴发调查建立一种标准化、基于证据的流行病学调查工具，扩大独立暴发调查的范围，并展示全国 CF 护理中心内医源性 NTM 传播的频率和性质。此外，它将为与医源性 NTM 传播相关的危险因素建模提供有价值的见解，并为未来的感染预防和控制指南提供更好的信息。本研究将系统地描述 CF 医疗环境灰尘和水生物膜中与临床相关的 NTM 分离株，并为描述医疗环境中与临床相关的 NTM 分离株最常见的环境来源奠定基础。
ClinicalTrials.gov NCT04024423。注册日期 2019 年 7 月 18 日。
