PREDICT Trial: PRospective Evaluation of NTM Disease In CysTic Fibrosis

Launched by NATIONAL JEWISH HEALTH · Feb 25, 2014

Keywords

ClinConnect Summary

This is an observational study called PREDICT (with a follow-on PART B called PATIENCE) focused on people with cystic fibrosis (CF) who have a positive test for non-tuberculous mycobacteria (NTM) in their lungs. The study aims to understand how NTM disease is diagnosed and tracked in CF, and to collect real-world data to guide future treatment research. It will enroll about 200 CF patients aged 6 years or older who have not yet been treated for the specific NTM they tested positive for, and who are willing to stop long-term azithromycin while in the study. Participants are seen at many CF centers across the United States, and researchers will collect various samples (like blood and sputum) and health information over time.

Participants will be followed for about a year at a time, with key data collected every 12 months. The main goal is to determine what proportion meet the criteria for NTM disease, while secondary goals include tracking how many respiratory cultures are done, how NTM types vary by region, how many eligible CF patients with NTM join the study at each site, and how many with NTM disease go on to join the PATIENCE treatment part. The study also looks at CF health measures such as lung function (FEV1), growth, and CF-specific quality of life. This is not a drug trial; it’s an observational effort to standardize diagnosis and build a framework for future trials. Enrollment is ongoing by invitation, with completion expected around March 2025, and no results are available yet.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• • 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
• Exclusion Criteria:
• • 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