Healthcare-associated links in transmission of nontuberculous mycobacteria among people with cystic fibrosis (HALT NTM) study: Rationale and study design

• Published in: PloS one Vol. 16; no. 12; p. e0261628
• Main Authors: Gross, Jane E, Caceres, Silvia, Poch, Katie, Hasan, Nabeeh A, Davidson, Rebecca M, Epperson, L Elaine, Lipner, Ettie, Vang, Charmie, Honda, Jennifer R, Strand, Matthew, Strong, Michael, Saiman, Lisa, Prevots, D Rebecca, Olivier, Kenneth N, Nick, Jerry A
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 20.12.2021; Public Library of Science (PLoS)
• Subjects: Aerosols; Analysis; Biofilms; Biology and Life Sciences; Cross Infection - microbiology; Cross Infection - transmission; Cystic fibrosis; Cystic Fibrosis - complications; Cystic Fibrosis - microbiology; Design; Design standards; Diagnosis; Disease transmission; Drinking water; Epidemics; Epidemiology; Female; Genomic analysis; Health care; Health risks; Humans; Infections; Infectious diseases; Male; Medicine; Medicine and Health Sciences; Mycobacteria; Mycobacterium; Mycobacterium Infections, Nontuberculous - etiology; Mycobacterium Infections, Nontuberculous - transmission; Nontuberculous Mycobacteria; Outbreaks; Patients; Pediatrics; Research methodology; Risk analysis; Risk Factors; Study Protocol; Water supply; United States; United States > US
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0261628

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.