PREDICT Trial: PRospective Evaluation of NTM Disease In CysTic Fibrosis

Status:	Recruiting
Conditions:	Pulmonary
Therapuetic Areas:	Pulmonary / Respiratory Diseases
Healthy:	No
Age Range:	6 - 99
Updated:	2/1/2018
Start Date:	December 2013
End Date:	March 2023
Contact:	Marion Jones, RN
Email:	jonesm@njhealth.org
Phone:	(303) 398-1265

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

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.

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 who are able to reliably
expectorate sputum and/or willing to undergo sputum induction (if necessary)

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

We found this trial at

sites

CFF Adult Program, The University of Texas Southwestern Medical Center at Dallas

Dallas, Texas 75390

Principal Investigator: Raksha Jain, MD

Phone: 214-648-2817

from

Dallas, TX