Journal Article

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

Saiman, Lisa, Vang, Charmie, Strand, Matthew, Honda, Jennifer R., Hasan, Nabeeh A., Lipner, Ettie, Strong, Michael, Epperson, L. Elaine, Caceres, Silvia, Gross, Jane E., Prevots, D. Rebecca, Olivier, Kenneth N., Nick, Jerry A., Davidson, Rebecca M., Poch, Katie

2021

Overview

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.

• Publisher: Public Library of Science,Public Library of Science (PLoS)
• Subject: 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 / Observational studies / Outbreaks / Patients / Pediatrics / Research methodology / Risk analysis / Risk Factors / Study Protocol / Water supply