PREDICT Trial: PRospective Evaluation of NTM Disease In CysTic Fibrosis

Cystic Fibrosis Clinical Trial

— PREDICT  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02073409
• Other study ID #: NTM-OB-17 (PREDICT PART A)
• Status: Enrolling by invitation
• Start date: December 2013
• Est. completion date: March 2025

Study information

• Verified date: March 2024
• Source: National Jewish Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 the diagnosis 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 diagnosis differ widely between centers. This study is observational and follows current best practices. The study will help standardize the diagnosis and collect relevant data associated with the diagnosis of NTM disease to build a framework for future therapeutic trials.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 99 Years

Eligibility

Inclusion Criteria:

1. Written informed consent (and assent when applicable) obtained from participant or participant's legal representative

2. Enrolled in the CFF Patient Registry (CFF PR)

3. Be willing and able to adhere to study procedures in the context of clinical care, and other protocol requirements

4. Male or female participant = 6 years of age at enrollment

5. Diagnosis of CF consistent with the 2017 CFF Guidelines

6. NTM positive for a species or sub-species in the 2 years prior to enrollment that has never been treated.

7. Willing to discontinue chronic azithromycin use for the duration of the study

Exclusion Criteria:

1. Prior or ongoing antibiotic treatment of the same NTM species or sub-species for which the patient is being considered for this study

2. History of solid organ or hematological transplantation

3. 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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
National Jewish Health	Children's Hospital Colorado, Cystic Fibrosis Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion meeting the diagnosis of NTM disease		12 months intervals following study enrollment
Secondary	Adherence to PREDICT protocol: number of respiratory cultures obtained per participant per year, withdrawals and major deviations from protocol		12 months intervals following study enrollment
Secondary	Incidence and prevalence of NTM species/subspecies by geographical region		12 months intervals following study enrollment
Secondary	Proportion of eligible NTM positive individuals with CF enrolling in PREDICT by site		12 months intervals following study enrollment
Secondary	Proportion of PREDICT participants with NTM disease diagnosis who enroll in Part B PATIENCE		12 months intervals following study enrollment
Secondary	Clinical parameters and outcomes (FEV1, growth parameters, CFQ-R)		12 months intervals following study enrollment