Status:
RECRUITING
Clinical Evaluation of an IGRA Test for the Diagnosis of Active and Latent Tuberculosis
Lead Sponsor:
Assistance Publique Hopitaux De Marseille
Conditions:
TUBERCULOSIS
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Methodology This is a single-center study carried out as part of routine patient care. The aim of the study is to determine the performance of the 2nd generation TB-IGRA test in the diagnosis of tube...
Detailed Description
It is planned to include 500 patients. An enrolment of 455 subjects will enable us to demonstrate sensitivity-specificity levels of 92% for a 95% confidence interval and a 0.05 degree of precision. To...
Eligibility Criteria
Inclusion
- Individual at least 18 years of age
- Patient presenting for treatment of tuberculosis disease
- Having undergone or benefiting from screening for tuberculosis using a medically prescribed reference IGRA test.
- Informed patient who has not expressed opposition to participating in the study.
- French-speaking patient with unambiguous understanding of oral and written instructions.
Exclusion
- Persons in a period of exclusion from another study
- Pregnant, parturient or breast-feeding women;
- Person deprived of liberty by judicial or administrative decision
Key Trial Info
Start Date :
July 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06485895
Start Date
July 30 2024
End Date
February 1 2028
Last Update
August 1 2024
Active Locations (1)
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1
Assistance Publique Hopitaux de Marseille
Marseille, France