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

Status:	Recruiting
Conditions:	Pulmonary
Therapuetic Areas:	Pulmonary / Respiratory Diseases
Healthy:	No
Age Range:	6 - 99
Updated:	2/1/2018
Start Date:	January 2014
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 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.

Inclusion Criteria:

1. Previous participation in PREDICT and diagnosis of NTM disease for the same species of
NTM

2. Intention to treat for NTM disease for M. avium complex or M. abscessus complex

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

4. Signed informed consent to participate in data submission to the CFF Patient Registry

5. 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

Exclusion Criteria:

1. Pregnant or breastfeeding

2. 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, Johns Hopkins University

Baltimore, Maryland 21205

Principal Investigator: Keira Cohen, MD

Phone: 410-614-1409

from

Baltimore, MD