Tuberculosis Clinical Trial
Official title:
A Phase III Trial in Subjects Suspected to Have Tuberculosis, Comparing the Diagnostic Performance of C-Tb to QuantiFERON®-TB Gold In-Tube, in Combination With a Double Blind Randomized Split Body Safety Assessment of C-Tb Versus 2 T.U. Tuberculin PPD RT23 SSI (PPD)
Verified date | April 2016 |
Source | Statens Serum Institut |
Contact | n/a |
Is FDA regulated | No |
Health authority | European Union: European Medicines Agency |
Study type | Interventional |
Tuberculosis (TB) continues to be one of the most serious bacterial infections 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, PPD, the C-Tb test
is injected just under the skin and will, when positive, show redness and/or swelling at the
injection site while a negative test will leave no reactions. The investigators hope that
this new C-Tb skin test will be more precise (specific) than the PPD test, as the PPD test
e.g. may show a reaction if the person tested is BCG vaccinated.
The aim of this trial is to test the C-Tb skin test in volunteers suspected of having TB
disease.
With focus on age, HIV status and CD4 count the following analyses are done (in an overall
perspective):
- To compare the C-Tb test to a blood test, the QuantiFERON test.
- To compare the C-Tb test to the PPD test that is currently being used.
- To assess the safety of the C-Tb test.
Status | Completed |
Enrollment | 1190 |
Est. completion date | September 2014 |
Est. primary completion date | September 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A to 65 Years |
Eligibility |
Inclusion Criteria: HIV NEGATIVE PARTICIPANTS: 1. Participants between 5 and 65 years attending the TB clinic due to suspicion of TB disease 2. Infants, toddlers and children between 28 days and 4 years must either have symptoms or signs of TB or be in close contact to a smear positive pulmonary TB case (more than 6 hours/day for at least five days) 3. Is between 28 days and 65 years of age 4. Participant, parent or legal guardian has signed the informed consent 5. Is HIV negative confirmed by two rapid tests. However, children between 28 days and 4 years may have an unknown HIV status and may receive antiretroviral therapy (ART) or have breastfeeding mothers on ART 6. Is willing and likely to comply with the trial procedures 7. Is prepared to grant authorized persons access to their medical record HIV POSITIVE PARTICIPANTS: 1. Participants between 5 and 65 years attending the TB clinic due to suspicion of TB disease 2. Infants, toddlers and children between 28 days and 4 years must either have symptoms* or signs** of TB or be in close contact to a smear positive pulmonary TB case (more than 6 hours/day for at least five days) 3. Is between 28 days and 65 years of age 4. Participant, parent or legal guardian has signed the informed consent 5. Is HIV positive confirmed by: 1. two positive rapid tests or 2. 1 positive rapid test and an additional confirmatory ELISA test 6. A CD4 count has been done 7. Is willing and likely to comply with the trial procedures 8. Is prepared to grant authorized persons access to their medical record HIV NEGATIVE CONTROL GROUP: 1. Participant with no known contact to people infected with MTb and no signs or symptoms of TB. 2. Is between 5 and 11 years of age 3. Participant, parent or legal guardian has signed the informed consent 4. Is HIV negative confirmed by two rapid tests 5. Is willing and likely to comply with the trial procedures 6. Is prepared to grant authorized persons access to their medical record Exclusion Criteria: HIV NEGATIVE PARTICIPANTS: 1. Has a confirmed diagnosis of tuberculosis at Screening Visit 2. Has been vaccinated with a live vaccine within 6 weeks prior to the day of inclusion (e.g. MMR, yellow fever, oral typhoid vaccines) except BCG vaccine 3. Has been tuberculin (TST) tested less than 12 months prior to the day of inclusion 4. Is pregnant, breastfeeding or intending to get pregnant during the trial period 5. Is a female of child bearing potential (12 years of age or older) not willing to use effective barrier (including spermicidal gel), hormonal or intrauterine contraceptive measures during the trial period 6. Has an active disease affecting the lymphoid organs (e.g., Hodgkin's disease, lymphoma, leukaemia, sarcoidosis) 7. Has a current skin condition which interferes with the reading of the C-Tb and PPD e.g. tattoos, severe scarring, burns/sunburns, rash, eczema, psoriasis, or any other skin disease at or near the injection sites 8. Has a condition where blood drawings pose more than minimal risk for the participant, such as haemophilia, other coagulation disorders or significantly impaired venous access 9. 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 10. Has participated in previous clinical trials investigating the ESAT-6 and/or CFP-10 antigens 11. Has a condition which in the opinion of the investigator is not suitable for participation in the trial HIV POSITIVE PARTICIPANTS: 1. Has a confirmed diagnosis of tuberculosis at Screening Visit 2. Has been vaccinated with a live vaccine within 6 weeks prior to the day of inclusion (e.g. MMR, yellow fever, oral typhoid vaccines) 3. Has been tuberculin (TST) tested less than 12 months prior to the day of inclusion 4. Is pregnant, breastfeeding or intending to get pregnant during the trial period 5. Is a female of child bearing potential (12 years of age or older) not willing to use effective barrier (including spermicidal gel), hormonal or intrauterine contraceptive measures during the trial period 6. Has an active disease affecting the lymphoid organs except for HIV (e.g., Hodgkin's disease, lymphoma, leukaemia, sarcoidosis) 7. Has a known diagnosis of AIDS or is receiving antiviral therapy at the time of Screening Visit 8. Has a current skin condition which interferes with the reading of the C-Tb and PPD 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 participant, 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. Has a condition which in the opinion of the investigator is not suitable for participation in the trial HIV NEGATIVE CONTROL GROUP: 1. Has been vaccinated with a live vaccine within 6 weeks prior to the day of inclusion (e.g. MMR, yellow fever, oral typhoid vaccines) except BCG vaccine 2. Has been tuberculin (TST) tested less than 12 months prior to the day of inclusion 3. Has an active disease affecting the lymphoid organs (e.g., Hodgkin's disease, lymphoma, leukaemia, sarcoidosis) 4. Has a current skin condition which interferes with the reading of the C-Tb and PPD e.g. tattoos, severe scarring, burns/sunburns, rash, eczema, psoriasis, or any other skin disease at or near the injection sites 5. Has a condition where blood drawings pose more than minimal risk for the participant, such as haemophilia, other coagulation disorders, or significantly impaired venous access 6. 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 7. Has participated in previous clinical trials investigating the ESAT-6 and/or CFP-10 antigens 8. Has a condition which in the opinion of the investigator is not suitable for participation in the trial |
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 | M2 Karl Bremer Hospital | Bellville, Cape Town | Western Cape |
South Africa | Tiervlei Trial Centre, Karl Bremer Hospital | Bellville, Cape Town | Western Cape |
South Africa | Worthwhile Clinical Trials, Lakeview Hospital | Benoni 1501 | Gauteng |
South Africa | UCT Lung Institute, Groote Schuur Hospital | Cape Town | Western Cape |
South Africa | Be Part Yoluntu Centre | Paarl | Western Cape |
South Africa | Primecure Medicentre, Mercantile Hospital | Port Elizabeth | Eastern Cape |
South Africa | Setshaba Research Centre | Pretoria | Gauteng |
South Africa | Synexus Stanza Bopape Clinic | Pretoria | Gauteng |
South Africa | Synnyside Medi-Clinic | Pretoria | Gauteng |
Lead Sponsor | Collaborator |
---|---|
Statens Serum Institut |
South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate the diagnostic performance of C-Tb in relation to age, HIV and CD4 counts | Onset between the injections and 28 days after the injections | No | |
Primary | To evaluate the clinical safety of C-Tb, with emphasis on children and HIV positive participants | Onset between the injections and 28 days after the injections | Yes | |
Secondary | To evaluate the difference in sensitivity between C-Tb and QuantiFERON®-TB Gold in-Tube in trial participants with confirmed TB diagnosis, overall, and according to age and HIV status. | From injections to 2-3 days after the injections | No | |
Secondary | To evaluate the difference in sensitivity between C-Tb and Tuberculin PPD RT23 SSI in trial participants with confirmed TB diagnosis overall, and according to age and HIV status. | Onset between the injections and 28 days after the injections | No | |
Secondary | To evaluate the difference in specificity between C-Tb and QuantiFERON®-TB Gold in-Tube in the control group of 100 children aged 5 - 11 years with no TB symptoms and no known exposure to MTb overall, and according to age. | From injections to 2-3 days after the injections | No | |
Secondary | To evaluate the difference in specificity between C-Tb and Tuberculin PPD RT23 SSI in the control group of 100 children aged 5 - 11 years with no TB symptoms and no known exposure to MTb overall, and according to age. | Onset between the injections and 28 days after the injections | No | |
Secondary | To compare the diagnostic outcome of C-Tb to that of QuantiFERON®-TB Gold in-Tube using a latent class approach | From injections to 2-3 days after the injections | No | |
Secondary | To compare the diagnostic outcome of C-Tb to that of Tuberculin PPD RT23 SSI using a latent class approach | Onset between the injections and 28 days after the injections | No | |
Secondary | To evaluate the diagnostic performance of Tuberculin PPD RT23 SSI in relation to age, HIV status and CD4 counts | Onset between the injections and 28 days after the injections | No | |
Secondary | To evaluate the clinical safety of Tuberculin PPD RT23 SSI | Onset between the injections and 28 days after the injections | Yes | |
Secondary | To evaluate the diagnostic performance of QuantiFERON®-TB Gold in-Tube in relation to age, HIV status and CD4 counts | On the day of the injections | No |
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