Purpose

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.

Condition

Eligibility

Eligible Ages
Between 6 Years and 99 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Observational
Observational Model
Case-Only
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

Tulane University
New Orleans, Louisiana
Contact:
Carol Rockwell
504-988-2325
crockwell@tulane.edu

More Details

Status
Recruiting
Sponsor
National Jewish Health

Study Contact

Valerie Lovell, RN
(303) 398-1265
lovellv@njhealth.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.