NCT02419989

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 70 (estimated)
• Sponsor: National Jewish Health · Academic / Other
• Sex: All
• Age: 6 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cystic Fibrosis

Timeline

• Start date: 2014-01-01
• Primary completion: 2025-03-01
• Completion: 2025-03-01
• First posted: 2015-04-17
• Last updated: 2024-04-02

Locations

19 sites across 1 country: United States