Summary

Eligibility
for people ages 6-99 (full criteria)
Location
at San Diego, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Douglas Conrad, MD

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 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.

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. 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

You CAN'T join if...

  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

Locations

  • University of California San Diego accepting new patients
    San Diego California United States
  • Children's Hospital of Los Angeles accepting new patients
    Los Angeles California United States

Lead Scientist at UCSD

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
National Jewish Health
ID
NCT02073409
Study Type
Observational
Last Updated