Prospective Evaluation of a Standardized Approach to Diagnosis (PREDICT) and Treatment (PATIENCE) of Nontuberculous Mycobacteria Disease in Cystic Fibrosis
What is the goal of the study?
Approximately 200 participants with CF who are 6 years of age and older and who have had a recent positive NTM culture will be systematically evaluated for NTM disease. Participants will be identified based on positive culture results obtained within the course of standard of care and enrolled into the study. Follow-up visits will be scheduled based on clinical need (per CFF guidelines). Participants will be evaluated for NTM disease and CF-related comorbidities following the PREDICT Study protocol. Participants who meet diagnostic criteria for NTM disease will be offered the opportunity to participate in the observational PART B (PATIENCE) portion that will evaluate response to a standardized NTM treatment algorithm based on current national guidelines for standards of care. Participants will be followed clinically monthly to monitor tolerability, toxicity, and effectiveness of antibiotic treatment. Participants will be evaluated until NTM is successfully eradicated and then for an additional year to assess the durability of the response to treatment. If side effects, drug intolerance, or poor treatment response occurs, treatment will be adjusted per the PATIENCE NTM Treatment Guidelines. NTM isolated from participants at the SCH clinical microbiology lab will be sent to National Jewish Health for additional microbiologic and molecular testing. Research samples to include blood, urine and sputum will be periodically collected and banked for future evaluation of treatment response and culture-independent methods for diagnosis (e.g. inflammatory mediators, sputum microbiome and other potential biomarkers).
Who can participate in the study?
Please contact the study team listed below to learn more.