Prospective Evaluation of a Standardized Approach to Diagnosis (PREDICT) and Treatment (PATIENCE) of Nontuberculous Mycobacteria Disease in Cystic Fibrosis

Status: Enrolling_by_invitation
Location: See all (19) locations...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 99
Healthy Volunteers: f
View:

• 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

Locations
United States
Alabama
CFF Pediatric Program, University of Alabama
Birmingham
California
Children's Hospital of Los Angeles
Los Angeles
University of California San Diego
San Diego
Colorado
Children's Hospital Colorado
Aurora
National Jewish Health
Denver
Florida
University of Florida
Gainesville
Illinois
Northwestern University
Chicago
Massachusetts
Boston Children's Hospital, Brigham & Women's Hospital
Boston
Maryland
CFF Adult Program, Johns Hopkins University
Baltimore
Michigan
CFF Pediatric Program University of Michigan
Ann Arbor
North Carolina
CFF Adult Program, University of North Carolina at Chapel Hill
Chapel Hill
New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon
New York
CFF Pediatric Program, Columbia University
New York
Ohio
Nationwide Children's Hospital
Columbus
Pennsylvania
University of Pittsburgh
Pittsburgh
Texas
CFF Adult Program, The University of Texas Southwestern Medical Center at Dallas
Dallas
Vermont
University of Vermont Medical Center
Burlington
Washington
CFF Adult Program, University of Washington
Seattle
CFF Pediatric Program Seattle Children's Hospital
Seattle
Time Frame
Start Date: 2014-01
Completion Date: 2025-03
Participants
Target number of participants: 70
Treatments
CF patients
Male and female subjects with CF age 6 years and older who meet diagnostic criteria for NTM disease through participation in the PREDICT (Part A) study who are being offered NTM treatment.
Related Therapeutic Areas
Sponsors
Collaborators: Children's Hospital Colorado, Cystic Fibrosis Foundation
Leads: National Jewish Health

This content was sourced from clinicaltrials.gov