drugset / Trial / NCT01779102

Safety Study Investigating if Concomitant Injections of C-Tb and 2 T.U Tuberculin Affect Induration Responses

NCT01779102 ↗

Phase 2/3 Completed 456 enrolled Statens Serum Institut
RandomizedParallel-groupQuadruple-blindDiagnostic

Summary

A new, more specific skin test to detect tuberculosis has been developed by Statens Serum Institut in Denmark. The new skin test is named C-Tb and like the current Tuberculin a positive test result will show as redness and/or induration at the injection site, while a negative test will leave no reactions. The aim of this study is to address if the size of induration and the sensitivity of C-Tb is influenced by concomitant injections of C-Tb and Tuberculin. Furthermore, the intention is to evaluate the safety of C-Tb when injected alone or concomitantly with Tuberculin.

Timeline

Start
2013-10
Primary completion
2014-09
Completion
2014-09

Drugs

EvaluationDrugModalityDoseRoute
Subject C-Tb Diagnostic / imaging agent 0.1 ug Other
Comparator Tuberculin PPD RT 23 SSI Diagnostic / imaging agent 2 unknown Other

Indications