Detection of Lipoarabinomannan in Urine Evaluation of the STANDARDTMF TBLAMFIA and Its Impact on the Initial TB Diagnosis

Launched by OSPEDALE SAN RAFFAELE · Mar 5, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new test called the STANDARD™ F TB LAM Ag FIA, which helps diagnose tuberculosis (TB) infection by detecting a specific substance in urine. The goal is to see how well this test works for identifying active TB cases early on, which can be crucial for getting patients the treatment they need right away.

To participate in the trial, adults aged 18 and older must either have documented active pulmonary TB, which affects the lungs, or be healthy volunteers with no risk factors for TB. Participants will need to sign a consent form agreeing to take part in the study. Those who qualify will help researchers understand how effective this test is in diagnosing TB, potentially improving the way this disease is identified in the future. It's important to know that this study is not recruiting participants yet, so there will be more details available when enrollment begins.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Inclusion criteria for PTB, PNTM and extraPTB:
• • Adult subjects with documented active pulmonary TB, pulmonary NTM or extrapulmonary TB
• • Subjects who have signed informed consent
• • Aged ≥18 years
• Inclusion criteria for HC:
• • healthy donors who have signed informed consent
• • aged ≥ 18 years
• • no TB or NTM risk factors or exposure
• Exclusion Criteria:
• Exclusion criteria for PTB, PNTM and extraPTB:
• • Do not have active pulmonary TB, NTM or extrapulmonary TB
• • Do not sign the informed consent
• • Are aged \< 18 years
• Exclusion criteria for HC:
• • Have active pulmonary TB or NTM
• • Do not sign the informed consent
• • Are aged \< 18 years