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A Trial in Subjects Suspected to Have Tuberculosis, Comparing the Diagnostic Performance of C-Tb to QuantiFERON®, in Combination With a Safety Assessment of C-Tb Versus Tuberculin PPD RT23 SSI

Statens Serum Institut · 2012
ClinicalTrials.gov · Datasets · License: Public Domain · 2012
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tuberculosis
Tuberculosis (TB) continues to be one of the most serious bacterial infections 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, PPD, the C-Tb test is injected just under the skin and will, when positive, show redness and/or swelling at the injection site while a negative test will leave no reactions. The investigators hope that this new C-Tb skin test will be more precise (specific) than the PPD test, as the PPD test e.g. may show a reaction if the person tested is BCG vaccinated. The aim of this trial is to test the C-Tb skin test in volunteers suspected of having TB disease. With focus on age, HIV status and CD4 count the following analyses are done (in an overall perspective): * To compare the C-Tb test to a blood test, the QuantiFERON test. * To compare the C-Tb test to the PPD test that is currently being used. * To assess the safety of the C-Tb test.
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