Tuberculosis
Conditions
Interventions
This is a prospective, randomized, controlled, double-blind clinical study. The participating centers will test two recombinant tuberculins: the Chinese EC test and the Russian Diaskin test, both alon
D12.776.097.025.845
D12.776.828
Sponsors
Universidade Federal do Rio de Janeiro
Universidade Federal do Rio de Janeiro
Eligibility
Age
18 Years to 59 Years
Inclusion criteria
Inclusion criteria: Active tuberculosis group: adults between eighteen (18) and fifty-nine (59) years of age; both sexes; bacteriologically confirmed tuberculosis undergoing treatment; women with a negative urine pregnancy test and/or who are not breastfeeding; provision of the Free and Informed Consent Form. Group control: adults between eighteen (18) and fifty-nine (59) years of age; both sexes; asymptomatic; women with a negative urine pregnancy test and/or who are not breastfeeding; provision of the Free and Informed Consent Form
Exclusion criteria
Exclusion criteria: Active tuberculosis group: patients with diabetes mellitus; malignant neoplasm; immunosuppression with the use of immunobiological; Lupus Erythematosus; Crohn's disease; patients with fibromyalgia syndrome; in use of homeopathic medicine; subjects previously infected with non-tuberculous mycobacteria not indicated or not known; Individuals with documented positive skin test of tuberculin examination in the past (documented or referred by the participant), with report of exacerbated reaction defined as phlyctenule reaction. Control Group: patients with diabetes mellitus; malignant neoplasm; immunosuppression with the use of immunobiological; Lupus Erythematosus; Crohn's disease; patients with fibromyalgia syndrome; in use of homeopathic medicine; individuals previously infected with nontuberculous mycobacteria; individuals reporting contact with pulmonary tuberculosis in the past; individuals who reported treatment for active tuberculosis in the past; individuals with a positive tuberculin skin test in the past (documented or referred by the participant), with a report of an exacerbated reaction defined as a phlyctenule reaction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Calculate the sensitivity and specificity of the intradermal tests Diaskin (Russian) and EC (Chinese) in detecting Mycobacterium tuberculosis infection in individuals with active tuberculosis and asymptomatic individuals without known exposure to Mycobacterium tuberculosis in different regions of Brazil | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the performance of the intradermal tests Diaskin (Russian) and EC (Chinese) in comparison to the sensitivity and specificity of the Purified Protein Derivative RT-23 (PPD RT-23) and QuantiFERON-TB Gold Plus (QFT-Plus). | — |
Countries
Brazil
Contacts
Public ContactAfrânio Kritski
Universidade Federal do Rio de Janeiro
Outcome results
None listed