Prospective Analysis of Urine LAM to Eliminate NTM Sputum Screening

Part of paid clinical trials in Denver, Colorado.

Sponsor
Jerry A. Nick, M.D.
Study ID
NCT04579211
Status
Enrolling By Invitation

Conditions

  • Cystic Fibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Dec 10, 2020
Status verified
May 2025
Primary completion
Apr 1, 2025
Completion
May 1, 2026

Study Design

Enrollment
220 participants (estimated)

Arms

  • Arm: Adults with a diagnosis of CF with history of negative NTM sputum cultures
    Male or female participants age 18 or greater at time of enrollment with diagnosis of CF consistent with the 2017 CFF Guidelines and NTM culture status of negative, as defined by a review of at least 3 year or more years of culture data and at least 3 NTM negative cultures with one of those negative cultures being within the last 3 years and no known history of previous positive cultures for pathogenic NTM by chart review.

Primary Outcome Measure

To determine the ability of the urine LAM assay to predict continued negative sputum culture over the next 12 months. [ Time Frame: From time enrollment to over the next 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
National Jewish HealthDenverColorado80206-

Find similar trials in Denver, CO

By research site
National Jewish Health· Denver, CO

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