A Trial of the C-Tb Skin Test, When Given Intradermally to Adult Patients Recently Diagnosed With… (NCT01241188) | Clinical Trial Compass
CompletedPhase 2
A Trial of the C-Tb Skin Test, When Given Intradermally to Adult Patients Recently Diagnosed With Active Tuberculosis (TB)
South Africa253 participantsStarted 2011-04
Plain-language 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).
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Has signed an informed consent
✓. Aged 18 to 65 years
✓. Has been diagnosed with active TB:
✓. has a compatible clinical picture of TB according to South African guidelines with the intention to treat and at least 1 documented positive sputum smear microscopy result or
✓. has a compatible clinical picture of TB according to South African Guidelines with the intention to treat and a positive culture result
✓. Is HIV negative confirmed by 2 two rapid tests (Abbott-DetermineTM HIV-1/2 and Sensa (Seyama Solutions, SA))
✓. Is willing and likely to comply with the trial procedures
✓. Is prepared to grant authorized persons access to their medical record
Exclusion criteria
✕. Has been in treatment for TB for more than 2 weeks
✕
What they're measuring
1
The diameter of induration at the injection sites measured transversely to the long axis of the forearm 2-3 days after application of the agents
Timeframe: From injections to 2-3 days after aplication
✕. Has within 3 months prior to the day of inclusion been in treatment with a product which is likely to modify the immune response except for HIV treatment (e.g., immunoglobulin, systemic corticosteroids, methotrexate, azathioprine, cyclosporine or blood products)
✕. Has been vaccinated with a live vaccine within 6 weeks prior to the day of inclusion (e.g. MMR, yellow fever, oral typhoid vaccines)
✕. Has been vaccinated with BCG \< 6 months prior to the day of inclusion
✕. Has been tuberculin (TST) tested \< 6 months prior to the day of inclusion
✕. Has an active disease affecting the lymphoid organs except for HIV (e.g., Hodgkin's disease, lymphoma, leukaemia, sarcoidosis)
✕. Has a current skin condition which interferes with the reading of the skin tests e.g. tattoos, severe scarring, burns/sunburns, rash, eczema, psoriasis, or any other skin disease at or near the injection sites