Clinical trial NCT06306430: Detection of Lipoarabinomannan in Urine Evaluation of the STANDARDTMF TBLAMFIA and Its Impact on the Initial TB Diagnosis
Official title: Detection of Lipoarabinomannan in Urine, Evaluation of the STANDARDTM F TB LAM FIA and Its Impact on the Initial Diagnosis of TB
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Tuberculosis
Diagnoses Disease
Lead sponsor: Ospedale San Raffaele
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects attending the Infectious Diseases Ward of the participating centers with a pulmonary TB, pulmonary NTM or extrapulmonary TB. Healthy controls,

Brief summary: Evaluation of the performance of an in vitro test, the STANDARDTM F TB LAM Ag FIA (SD BIOSENSOR, INC.) for the early diagnosis of tuberculosis (TB) infection. This test is for in vitro professional diagnostic use and intended as an aid to early diagnosis of tuberculosis infection. The test will be used according to the instructions for use (IFU).

Detailed description: STANDARDTM F TB LAM Ag FIA is a fluorescent immunoassay which detects lipoarabinomannan in human urine sample. The test evaluated in this study may provide benefits for the development of non sputum-based, less invasive tuberculosis diagnostics that include easier to collect biological samples. The study can therefore be relevant for updating WHO guidelines for TB diagnosis. The results of the STANDARDTM F TB LAM Ag FIA will be interpreted according to the manufacturer´s instructions and will be compared to the results of the test performed to confirm the pulmonary TB, the extrapulmonary TB or the pulmonary NTM diagnosis (intention to treat assay). The test will be repeted at the end of the anti-TB therapy to evaluate if the test can be used as marker of treatment response. Healthy subjects without exposure or risk for TB factors will serve as a proxy for specificity; subjects with confirmed TB will serve as control group to estimate sensitivity.

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

Primary outcomes:
measure: Evaluate the diagnostic performance of a new test based on the detection of lipoarabinomannan (LAM) antigen in human urine using immunoassay
timeFrame: 12 months
Secondary outcomes:
measure: Exploratory Objectives Evaluate if the test can be used as marker of treatment response (only for PTB subjects)
timeFrame: 6 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Emerging Bacterial Pathogens Unit
Study officials:
References: