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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.1 µg C-Tb | Experimental | The C-Tb agent is given alone to volunteers in the RIGHT or LEFT forearm according to a double blind randomisation scheme |
|
| 2 T.U Tuberculin PPD RT 23 SSI | Active Comparator | The 2 T.U Tuberculin PPD RT 23 SSI agent is given alone to volunteers in the RIGHT or LEFT forearm according to a double blind randomisation scheme |
|
| 0.1 µg C-Tb / 2 T.U Tuberculin PPD | Experimental | The C-Tb and 2 T.U Tuberculin PPD RT 23 SSI agents are given concomitantly to volunteers in the RIGHT and LEFT forearms according to a double blind randomisation scheme |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C-Tb | Biological | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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 | Onset from the injection(s) to 28 days after the injections |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria (HIV Negative patients):
Has signed an informed consent
Aged 18 to 65 years
Has been diagnosed with active pulmonary TB:
Is HIV negative confirmed by 2 two rapid tests
Is willing and likely to comply with the trial procedures
Is prepared to grant authorized persons access to their medical record
Inclusion Criteria (HIV Positive patients):
Has signed an informed consent
Aged 18-65 years
Has been diagnosed with active pulmonary TB:
Is HIV positive confirmed by:
A CD4 count has been performed
Is willing and likely to comply with the trial procedures
Is prepared to grant authorized persons access to their medical records
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pernille N Tingskov, BN, RN | Statens Serum Institut | Study Director |
| Keertan Dheda, MD, Prof | UCT Lung Institute, University of Cape Town | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TASK, M2, Karl Bremer Hospital, | Cape Town | Cape Town | 7530 | South Africa | ||
| Tiervlei Trial Centre, Karl Bremer Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30572979 | Derived | Aggerbeck H, Ruhwald M, Hoff ST, Tingskov PN, Hellstrom E, Malahleha M, Siebert M, Gani M, Diacon A, Novelijc Z, Andersen P, Dheda K. Interaction between C-Tb and PPD given concomitantly in a split-body randomised controlled trial. Int J Tuberc Lung Dis. 2019 Jan 1;23(1):38-44. doi: 10.5588/ijtld.18.0137. Epub 2018 Dec 20. |
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| Tuberculin PPD RT 23 SSI | Biological | Tuberculin is administered by the Mantoux injection technique to each volunteer in the RIGHT or LEFT forearm according to a double blind randomisation scheme |
|
| C-Tb / Tuberculin PPD RT 23 SSI | Biological | 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 |
|
| 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 | Onset from the injection(s) to 28 days after the injections |
| Cape Town |
| Cape Town |
| 7530 |
| South Africa |
| UCT Lung Institute | Cape Town | Cape Town | 7925 | South Africa |
| Primecure Medicentre | Port Elizabeth | Port Elizabeth | 6014 | South Africa |
| Synexus Stanza Bopape Clinic | Pretoria | Pretoria | 0122 | South Africa |
| Setshaba Research Centre | Pretoria | Pretoria | 0152 | South Africa |
| Be Part Yoluntu Centre | Paarl | Western Cape | 7626 | South Africa |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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