Validation of recombinant proteins in Tuberculosis diagnosis

Not Applicable

Recruiting

• Conditions: Tuberculosis Pulmonary; CID 10 - A15

• Registration Number: RBR-7tn2ysw
• Lead Sponsor: niversidade Federal do Rio de Janeiro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-25
• Last Update Posted: 13 November 2023
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Active tuberculosis group; adults between eighteen (18) and fifty-nine (59) years of age; 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; asymptomatic; women with a negative urine pregnancy test and/or who are not breastfeeding; provision of the Free and Informed Consent Form

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;

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
It is expected to calculate the sensitivity and specificity of the Diaskin and EC tests, using the Mantoux technique and reading the tuberculin test after 72 hours (up to 96 hours) after the applications of the tuberculins (EC and PPD RT23 OR Diaskintest and PPD RT23) these measures should be noted in milimeters