PATIENCE Trial: Prospective Algorithm for Treatment of NTM in Cystic Fibrosis

Status unconfirmed

Conditions studied: Cystic Fibrosis

In brief

Isolation of nontuberculous mycobacteria (NTM) from the sputum of individuals with CF is an increasingly common finding, and the lack of an evidenced-based approach to treatment of NTM disease has been identified as one of the greatest unmet needs within the CF community. Current evidence predicts that the prevalence of NTM will remain relatively high in the CF population. Approaches to NTM disease treatment differ widely between centers, and expected outcomes are not known. This study is observational and follows current best practices. The study will help define response to treatment, and collect relevant data associated with treatment of NTM disease to build a framework for future therapeutic trials.

Key facts

Study ID

NCT02419989

Run by

National Jewish Health

People needed

70

Starts

2014-01-01

Expected to finish

2025-03-01

Last updated by the study team

2024-04-02

Who can join

Age: 6 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Previous participation in PREDICT and diagnosis of NTM disease for the same species of NTM
• Intention to treat for NTM disease for M. avium complex or M. abscessus complex
• Written informed consent (and assent when applicable) obtained from participant or participant's legal representative
• Signed informed consent to participate in data submission to the CFF Patient Registry
• Be willing and able to initiate treatment for NTM and to adhere to study procedures in the context of clinical care, and other protocol requirements

You may not qualify if…

• Pregnant or breastfeeding
• Has any other condition that, in the opinion of the Site Investigator/designee, would preclude informed consent or assent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives

Where it is running

• CFF Pediatric Program, University of Alabama — Birmingham, Alabama, United States
• Children's Hospital of Los Angeles — Los Angeles, California, United States
• University of California San Diego — San Diego, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• National Jewish Health — Denver, Colorado, United States
• University of Florida — Gainesville, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• CFF Adult Program, Johns Hopkins University — Baltimore, Maryland, United States
• Boston Children's Hospital, Brigham & Women's Hospital — Boston, Massachusetts, United States
• CFF Pediatric Program University of Michigan — Ann Arbor, Michigan, United States
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
• CFF Pediatric Program, Columbia University — New York, New York, United States
• CFF Adult Program, University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• CFF Adult Program, The University of Texas Southwestern Medical Center at Dallas — Dallas, Texas, United States
• University of Vermont Medical Center — Burlington, Vermont, United States
• CFF Pediatric Program Seattle Children's Hospital — Seattle, Washington, United States
• CFF Adult Program, University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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