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

Summary

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

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

  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

You CAN'T join if...

  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

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
Completion Date
(estimated)
Sponsor
National Jewish Health
ID
NCT02419989
Study Type
Observational
Participants
Expecting 70 study participants
Last Updated