Prospective Analysis of Urine LAM to Eliminate NTM Sputum Screening

Cystic Fibrosis Clinical Trial

— PAINLESS  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04579211
• Other study ID #: NICK20A0 20-08-402-528
• Status: Enrolling by invitation
• Start date: December 10, 2020
• Est. completion date: October 2025

Study information

• Verified date: March 2024
• Source: National Jewish Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 220
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Informed consent obtained online or in person from the participant

• Enrolled in the CFF Patient Registry (CFFPR)

• Be willing and able to adhere to study procedures in the context of clinical care, and other protocol requirements

• Diagnosis of CF consistent with the 2017 CFF Guidelines NTM culture status of negative (defined by a review of clinical and culture data with at least 3 years of clinical data available to review and at least one negative culture within the year prior to enrollment and no known history of previous positive cultures for pathogenic NTM)

Exclusion Criteria:

1. 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

Related Conditions & MeSH terms

• Cystic Fibrosis

Intervention

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.

Locations

Country	Name	City	State
United States	National Jewish Health	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Jerry A. Nick, M.D.

Country where clinical trial is conducted

United States, 

References & Publications (1)

De P, Amin AG, Graham B, Martiniano SL, Caceres SM, Poch KR, Jones MC, Saavedra MT, Malcolm KC, Nick JA, Chatterjee D. Urine lipoarabinomannan as a marker for low-risk of NTM infection in the CF airway. J Cyst Fibros. 2020 Sep;19(5):801-807. doi: 10.1016/j.jcf.2020.06.016. Epub 2020 Jul 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the ability of the urine LAM assay to predict continued negative sputum culture over the next 12 months.	Correlation of a negative NTM sputum culture in the year following a negative urine LAM assay	From time enrollment to over the next 12 months
Secondary	To determine the ability of the urine LAM assay to predict new positive NTM sputum culture over the next 12 months.	Correlation of a positive NTM sputum culture in the year following a positive urine LAM assay	From time of enrollment to over the next 12 months
Secondary	To determine the time between a positive LAM assay and a new positive NTM culture.	Correlation of a positive NTM sputum culture up to 3 years following a positive urine LAM assay	3 years
Secondary	To facilitate the development of a ELISA-based assay as a possible replacement to GC/MS in the clinical setting.	Excess urine will be used to develop and validate an alternative assay using ELISA.	3 years