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.
The TESEC-07 trial is a GCP double blind randomised controlled phase II/III trial investigating if concomitant injections of the diagnostic agents C-Tb and 2 T.U Tuberculin PPD RT 23 SSI affect the induration responses in combination with a safety assessment of C-Tb. TESEC-07 is a multi-centre trial and will be conducted in South Africa in patients recently diagnosed with TB comprising 360 HIV negative and 90 HIV positive adults allocated to 3 trial groups. * A within group paired comparison of 0.1 μg/0.1 mL C-Tb and PPD RT 23 in 150 TB patients. The C-Tb and PPD RT 23 agents are given concomitantly to each volunteer in the RIGHT AND LEFT forearms according to a randomisation scheme. * A group of 150 TB patients will only receive the C-Tb agent randomised to either RIGHT or LEFT forearm. * A group of 150 TB patients will only receive the reference agent PPD RT 23 randomised to either RIGHT or LEFT forearm.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Enrollment
456
C-Tb is administered by the Mantoux injection technique to each volunteer in the RIGHT or LEFT forearm according to a double blind randomisation scheme
Tuberculin is administered by the Mantoux injection technique to each volunteer in the RIGHT or LEFT forearm according to a double blind randomisation scheme
The C-Tb and Tuberculin agents are administered by the Mantoux injection technique to each volunteer in the RIGHT and LEFT forearm according to a double blind randomisation scheme
TASK, M2, Karl Bremer Hospital,
Cape Town, Cape Town, South Africa
Tiervlei Trial Centre, Karl Bremer Hospital
Cape Town, Cape Town, South Africa
UCT Lung Institute
Cape Town, Cape Town, South Africa
Primecure Medicentre
Port Elizabeth, Port Elizabeth, South Africa
Synexus Stanza Bopape Clinic
Pretoria, Pretoria, South Africa
Setshaba Research Centre
Pretoria, Pretoria, South Africa
Be Part Yoluntu Centre
Paarl, Western Cape, South Africa
To compare the size of induration of C-Tb and PPD RT 23 if injected alone or concomitantly in Tuberculosis infected patients (HIV positives and HIV negatives)
Time frame: Onset from the injection(s) to 28 days after the injections
To assess if concomitant injections of C-Tb and PPD RT 23 influence the tests abilities to identify positive results of Tuberculosis in Tuberculosis infected patients
Time frame: Onset from the injection(s) to 28 days after the injections
To compare the C-Tb test's ability to identify positive results in Tuberculosis infected patients with the in vitro QuantiFERON®TB Gold In Tube assay in blood collected immediately before application of the C-Tb skin test
Time frame: Onset from the injection(s) to 28 days after the injections
To compare the C-Tb test's ability to identify positive results in Tuberculosis infected patients with the PPD RT 23 test
Time frame: Onset from the injection(s) to 28 days after the injections
To assess the safety of C-Tb skin test by investigating laboratory safety parameters and assessing all adverse events (local and systemic) occurring within 28 days after administration of the C-Tb and/or PPD RT 23 tests
Time frame: Onset from the injection(s) to 28 days after the injections
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