Tuberculosis Clinical Trial
— TESEC-04Official title:
A Phase IIb Sensitivity Trial of the Diagnostic Agent C-Tb, When Given Intradermally by the Mantoux Technique to Adult Patients Recently Diagnosed With Active TB
Verified date | April 2015 |
Source | Statens Serum Institut |
Contact | n/a |
Is FDA regulated | No |
Health authority | South Africa: Medicines Control Council |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 253 |
Est. completion date | December 2011 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
South Africa | University of Cape Town Lung Institute (Pty) Ltd | Cape Town |
Lead Sponsor | Collaborator |
---|---|
Statens Serum Institut |
South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | From injections to 2-3 days after aplication | No | |
Secondary | Injection site adverse reactions within 28 days after application of the agents | Onset between the injections and 28 days after the injections | Yes | |
Secondary | All adverse events occurring within 28 days after application of the agents | Onset between the injections and 28 days after the injections | Yes | |
Secondary | Laboratory safety parameters of haematology and biochemistry | Onset between the injections and 28 days after the injections | Yes | |
Secondary | In vitro IFN-? response as measured by the QuantiFERON®-TB Gold In Tube assay | Onset between the injections and 28 days after the injections | No |
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