This study is accepting new patients by invitation only

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

a study on Cystic Fibrosis Fibrosis Nontuberculous Mycobacteria

Eligibility: for people ages 6-99 (full criteria)
Location: at San Diego, California and other locations
Dates: study started January 2014
completion around March 2025

Description

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.

Official Title

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

Keywords

Cystic Fibrosis, Nontuberculous Mycobacteria, Fibrosis

Eligibility

You can join if…

Open to people ages 6-99

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

You CAN'T join if...

Pregnant or breastfeeding
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

Locations

University of California San Diego
San Diego California United States
Children's Hospital of Los Angeles
Los Angeles California United States

Details

Status: accepting new patients by invitation only
Start Date: January 2014
Completion Date: March 2025 (estimated)
Sponsor: National Jewish Health
ID: NCT02419989
Study Type: Observational
Participants: Expecting 70 study participants
Last Updated: March 2024