Status:
COMPLETED
A Trial of the C-Tb Skin Test, When Given Intradermally to Adult Patients Recently Diagnosed With Active Tuberculosis (TB)
Lead Sponsor:
Statens Serum Institut
Conditions:
Tuberculosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 ...
Detailed Description
The trial is designed to investigate the sensitivity of C-Tb using various sizes of cut-off of induration in a double blind randomised, split-body study comparing 0.1 µg/0.1 mL C-Tb with the reference...
Eligibility Criteria
Inclusion
- Inclusion Criteria (HIV negative patients):
- 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
- Inclusion Criteria (HIV positive patients):
- Has signed an informed consent
- Aged 18 to 65 years
- Has a compatible clinical picture of TB according to South African guidelines with the intention to treat
- Is HIV positive confirmed by:
- 2 positive rapid tests (Abbott-DetermineTM HIV-1/2 and Sensa (Seyama Solutions, SA)) or
- 1 positive rapid tests (Abbott-DetermineTM HIV-1/2 or Sensa (Seyama Solutions, SA)) and an additional confirmatory ELISA (Enzygnost anti-HIV-1/2 Plus)
- Is willing and likely to comply with the trial procedures
- Is prepared to grant authorized persons access to their medical records
- Exclusion Criteria:
- Has been in treatment for TB for more than 2 weeks
- Has a known MDR/XDR-TB
- 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
- Has a condition where blood drawings pose more than minimal risk for the patient, such as haemophilia, other coagulation disorders, or significantly impaired venous access
- Currently participating in another clinical trial with an investigational or non investigational drug or device, or has participated in another clinical trial within the 3 months prior to dosing
- Has participated in previous clinical trials investigating the ESAT-6 and/or CFP-10 antigens
- Is pregnant, breastfeeding or intending to get pregnant
- Has a condition which in the opinion of the investigator is not suitable for participation in the study
Exclusion
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
253 Patients enrolled
Trial Details
Trial ID
NCT01241188
Start Date
April 1 2011
End Date
December 1 2011
Last Update
April 17 2015
Active Locations (1)
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1
University of Cape Town Lung Institute (Pty) Ltd
Cape Town, Cape Town, South Africa, 7925