NCT04579211

Prospective Analysis of Urine LAM to Eliminate NTM Sputum Screening

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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 220 (estimated)
• Sponsor: Jerry A. Nick, M.D. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	urine lipoarabinomannan (LAM)	Investigate the utility of urine LAM as a test to identify individuals at very low risk for having a sputum culture positive for NTM.

Timeline

• Start date: 2020-12-10
• Primary completion: 2025-04-01
• Completion: 2026-05-01
• First posted: 2020-10-08
• Last updated: 2025-05-23

Locations

1 site across 1 country: United States