Tuberculosis Clinical Trial
Official title:
A Phase III Contact Tracing Trial 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
Verified date | April 2015 |
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 the most important bacterial infection worldwide and
therefore new improved diagnostic tests are needed to help doctors in diagnosing TB.
We are investigating a new skin test 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 aim of this trial is to test the C-Tb skin test in volunteers. The volunteers are
divided into four groups:
- Negative control group: Must have no history of exposure to a person with tuberculosis
disease.
- Occasional contact: Must be in contact with a person with tuberculosis disease between
6 hours/week and 6 hours/day
- Close contact: Must be in close contact with a person with tuberculosis disease for
more than 6 hours/day for at least five days
- Positive control group: Must have a confirmed tuberculosis disease within the last 3
years.
The goals of this clinical trial are:
- 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 | 979 |
Est. completion date | October 2014 |
Est. primary completion date | October 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 6 Weeks to 65 Years |
Eligibility |
Inclusion Criteria: 1. Can comply with one of the following groups: 1. Negative control group: Must have no history of exposure to a TB index case, and have no signs or symptoms of TB 2. Positive control group: Confirmed TB disease within the last 3 years by sputum smear microscopy and/or Culture, Gene Xpert or PCR 3. Close contact group: Must be in close contact with a pulmonary smear positive TB index case for more than 6 hours/day for at least five days 4. Occasional contact group: Must be in contact with a pulmonary sputum smear positive TB index case between 6 hours/week and 6 hours/day 2. Is between 6 weeks - 65 years of age 3. Participant, parent or legal guardian has provided signed informed consent 4. Is willing and likely to comply with the trial procedures 5. Is prepared to grant authorized persons access to their medical records Exclusion Criteria: 1. Has been vaccinated with a live vaccine within 6 weeks prior to the day of inclusion (e.g. Mumps Measles Rubella (MMR), yellow fever, oral typhoid vaccines) 2. Has been tuberculin tested less than 12 months prior to the day of inclusion 3. Is pregnant, breastfeeding or intending to get pregnant within the trial period 4. Is a female of child bearing potential (12 years of age or older having had their first menstruation) not willing to use effective barrier (including spermicidal gel), hormonal or intrauterine contraceptive measures within the trial period 5. Has an active disease affecting the lymphoid organs except for HIV (e.g., Hodgkin's disease, lymphoma, leukaemia, sarcoidosis) 6. Has a current skin condition which interferes with the reading of the C-Tb and Tuberculin PPD RT23 SSI e.g. tattoos, severe scarring, burns/sunburns, rash, eczema, psoriasis, or any other skin disease at or near the injection sites 7. 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 8. Current participation in another clinical trial with an investigational or non investigational drug or device, which in the opinion of investigator may interfere with this trial drug 9. Has participated in previous clinical trials investigating injections with ESAT-6 and/or CFP-10 antigens 10. 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 |
---|---|---|---|
Spain | Hospital Universitario de Cruces | Barakaldo | Basque Country |
Spain | CAP Drassanes, Unitat de Prevenció i Control de Tuberculosi | Barcelona | Catalonia |
Spain | Hospital Clínic i Provincial de Barcelona | Barcelona | Catalonia |
Spain | Hospital de la Santa Creu i Sant Pau | Barcelona | Catalonia |
Spain | Hospital del Mar | Barcelona | Catalonia |
Spain | Hospital Mutua de Terrassa | Barcelona | Catalonia |
Spain | Hospital San Joan De Deu | Barcelona | Catalonia |
Spain | Hospital Vall d'Hebron | Barcelona | Catalonia |
Spain | Public Health Agency of Barcelona | Barcelona | Catalonia |
Spain | Hospital Universitario Lucus Augusti | Lugo | Galicia |
Spain | Complexo Hospitalario de Pontevedra | Pontevedra | Galicia |
Spain | Complejo Hospitalario Universitario de Santiago | Santiago de Compostela | Galicia |
Spain | Complexo Hospitalario Universitario de Vigo | Vigo | Galicia |
Lead Sponsor | Collaborator |
---|---|
Statens Serum Institut |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To demonstrate an increasing trend in C-Tb test positivity across the four study groups, with 'positivity' defined as an induration = 5 mm | Onset between the injections and 28 days after the injections | No | |
Secondary | To demonstrate a significantly lower response rate of C-Tb as compared to that of PPD RT23 SSI in the BCG vaccinated participants in the negative control group, with response defined as any induration (> 1mm) for both agents | Onset between the injections and 28 days after the injections | No | |
Secondary | To evaluate a possible trend in C-Tb induration diameters across the four pre-specified MTb infection risk sub-groups | Onset between the injections and 28 days after the injections | No | |
Secondary | To evaluate a possible trend in PPD RT23 SSI induration diameters across the four pre-specified MTb infection risk sub-groups | Onset between the injections and 28 days after the injections | No | |
Secondary | To evaluate a possible trend in QuantiFERON Gold In-Tube results across four pre-specified MTb infection risk sub-groups | On the day of the injections | No | |
Secondary | To evaluate a possible trend in PPD RT23 SSI test positivity across four pre-specified MTb infection risk sub-groups | Onset between the injections and 28 days after the injections | No | |
Secondary | To evaluate a possible trend in QuantiFERON Gold In-Tube test positivity across four pre-specified MTb infection risk sub-groups | On the day of the injections | No | |
Secondary | To evaluate the difference in sensitivity between C-Tb and QuantiFERON Gold In-Tube in the positive control group | From the day of injections to 2-3 days after the injections | No | |
Secondary | To evaluate the difference in specificity between C-Tb and QuantiFERON Gold In-Tube in the negative control group | From the day of injections to 2-3 days after the injections | No | |
Secondary | To evaluate the difference in sensitivity between C-Tb and PPD RT23 SSI in positive control group | Onset between the injections and 28 days after the injections | No | |
Secondary | To evaluate the difference in specificity between C-Tb and PPD RT23 SSI in the negative control group | Onset between the injections and 28 days after the injections | No | |
Secondary | To compare the size of induration of C-Tb if injected alone or concomitantly with PPD RT23 SSI in negative control group | Onset between the injections and 28 days after the injections | No | |
Secondary | To compare the specificity of C-Tb if injected alone or concomitantly with PPD RT23 SSI, in the negative control group | Onset between the injections and 28 days after the injections | No | |
Secondary | To compare the diagnostic outcome of C-Tb to that of QuantiFERON Gold In-Tube using a latent class approach | From the day of injections to 2-3 days after the injections | No | |
Secondary | To compare the diagnostic outcome of C-Tb to that of PPD RT23 SSI using a latent class approach | Onset between the injections and 28 days after the injections | No | |
Secondary | To evaluate the secondary analyses above (1-14) of C-Tb and PPD RT23 SSI using alternative cut-off values | Onset between the injections and 28 days after the injections | No | |
Secondary | To compare the diagnostic outcome of C-Tb and QuantiFERON Gold In-Tube stratified on the four study groups | From the day of injections to 2-3 days after the injections | No | |
Secondary | To compare the diagnostic outcome of C-Tb and PPD RT23 SSI stratified on the four study groups | Onset between the injections and 28 days after the injections | No | |
Secondary | To evaluate the clinical safety of C-Tb | Onset between the injections and 28 days after the injections | Yes | |
Secondary | To evaluate the clinical safety of PPD RT23 SSI | Onset between the injections and 28 days after the injections | Yes |
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