A Trial of the C-Tb Skin Test, When Given Intradermally to Adult Patients Recently Diagnosed With Active Tuberculosis (TB)

Summary

Tuberculosis (TB) continues to be the most important bacterial infection worldwide and therefore new improved diagnostic tests are needed to help doctors in diagnosing TB. The new skin test is named C-Tb. Like the current Tuberculin Skin Test (TST), the C-Tb test is injected just under the skin and will when positive show a redness and/or swelling at the injection site while a negative test will leave no reactions. The aim of this trial is to test the C-Tb skin test in adults diagnosed with TB to determine if a TB infected individual has a truly positive test result (this is called to find the sensitivity of the skin test).

Timeline

Start

2011-04

Primary completion

2011-12

Completion

2011-12

Publications

• Hoff ST, Peter JG, Theron G, Pascoe M, Tingskov PN, Aggerbeck H, Kolbus D, Ruhwald M, Andersen P, Dheda K. Sensitivity of C-Tb: a novel RD-1-specific skin test for the diagnosis of tuberculosis infection. Eur Respir J. 2016 Mar;47(3):919-28. doi: 10.1183/13993003.01464-2015. Epub 2015 Dec 17.
• Aggerbeck H, Giemza R, Joshi P, Tingskov PN, Hoff ST, Boyle J, Andersen P, Lewis DJ. Randomised clinical trial investigating the specificity of a novel skin test (C-Tb) for diagnosis of M. tuberculosis infection. PLoS One. 2013 May 14;8(5):e64215. doi: 10.1371/journal.pone.0064215. Print 2013.

Drugs

Indications