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Prospective Analysis of Urine LAM to Eliminate NTM Sputum Screening (PAINLESS)

NCT04579211 ENROLLING_BY_INVITATION

This is a prospective, single-center, nonrandomized observational study to investigate the utility of urine lipoarabinomannan (LAM) as a test to identify individuals at very low risk for having a sputum culture positive for Nontuberculous Mycobacteria (NTM). The study is designed to evaluate if a urine test can eliminate the need for obtaining a sputum specimen to screen for NTM in individuals with Cystic Fibrosis (CF). The participants will be asked to provide 3 urine samples either in person or by mail over approximately 3 years. The 3 urine sample requests will be timed to coincide with their usual clinical care and routine sputum collection.

Details

Lead sponsorJerry A. Nick, M.D.
StatusENROLLING_BY_INVITATION
Enrolment220
Start dateThu Dec 10 2020 00:00:00 GMT+0000 (Coordinated Universal Time)
CompletionFri May 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Interventions

Countries

United States