Prospective Analysis of Urine LAM to Eliminate NTM Sputum Screening

Официальное название

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

Обзор

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.

Вмешательства

• Диагностический тест 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.

Первичные конечные точки

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

Вторичные конечные точки (3)

• To determine the ability of the urine LAM assay to predict new positive NTM sputum culture over the next 12 months. [Срок оценки: From time of enrollment to over the next 12 months]
• To determine the time between a positive LAM assay and a new positive NTM culture. [Срок оценки: 3 years]
• To facilitate the development of a ELISA-based assay as a possible replacement to GC/MS in the clinical setting. [Срок оценки: 3 years]

Критерии участия

Критерии включения

• 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)

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• National Jewish Health — Denver

Публикации

• 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. PMID 32624408

Идентификаторы

NCT: NCT04579211 · NICK20A0 20-08-402-528

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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