A Trial of the C-Tb Skin Test, When Given Intradermally to Adult Patients Recently Diagnosed With Active Tuberculosis (TB)

Launched by STATENS SERUM INSTITUT · Nov 15, 2010

Keywords

ClinConnect Summary

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 agent 2 T.U. Tuberculin PPD RT23 SSI. (Each volunteer receives the C-Tb agent in one arm and 2 T.U. Tuberculin PPD RT 23 SSI in the other arm). Two groups of adult patients recently diagnosed with active TB will be investigated; patients in the main group will NOT have a co-infection with HIV and patients in the second group will have a co-infection with HIV.

The C-Tb and 2 TU Tuberculin PPD ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria (HIV negative patients):
• • 1. Has signed an informed consent
• • 2. Aged 18 to 65 years
• 3. Has been diagnosed with active TB:
• • 1. 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
• • 2. has a compatible clinical picture of TB according to South African Guidelines with the intention to treat and a positive culture result
• • 4. Is HIV negative confirmed by 2 two rapid tests (Abbott-DetermineTM HIV-1/2 and Sensa (Seyama Solutions, SA))
• • 5. Is willing and likely to comply with the trial procedures
• • 6. Is prepared to grant authorized persons access to their medical record
• Inclusion Criteria (HIV positive patients):
• • 1. Has signed an informed consent
• • 2. Aged 18 to 65 years
• • 3. Has a compatible clinical picture of TB according to South African guidelines with the intention to treat
• 4. Is HIV positive confirmed by:
• • 1. 2 positive rapid tests (Abbott-DetermineTM HIV-1/2 and Sensa (Seyama Solutions, SA)) or
• • 2. 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)
• • 5. Is willing and likely to comply with the trial procedures
• • 6. Is prepared to grant authorized persons access to their medical records
• Exclusion Criteria:
• • 1. Has been in treatment for TB for more than 2 weeks
• • 2. Has a known MDR/XDR-TB
• • 3. 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)
• • 4. Has been vaccinated with a live vaccine within 6 weeks prior to the day of inclusion (e.g. MMR, yellow fever, oral typhoid vaccines)
• • 5. Has been vaccinated with BCG \< 6 months prior to the day of inclusion
• • 6. Has been tuberculin (TST) tested \< 6 months prior to the day of inclusion
• • 7. Has an active disease affecting the lymphoid organs except for HIV (e.g., Hodgkin's disease, lymphoma, leukaemia, sarcoidosis)
• • 8. 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
• • 9. 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
• • 10. 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
• • 11. Has participated in previous clinical trials investigating the ESAT-6 and/or CFP-10 antigens
• • 12. Is pregnant, breastfeeding or intending to get pregnant
• • 13. Has a condition which in the opinion of the investigator is not suitable for participation in the study