Comparison of Diagnostic Performance of C-Tb to QuantiFERON®-TB, in Combination With a Safety Assessment of C-Tb vs Tuberculin PPD RT23 SSI
NCT ID: NCT01631266
Last Updated: 2015-04-17
Study Results
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Basic Information
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COMPLETED
PHASE3
979 participants
INTERVENTIONAL
2012-07-31
2014-10-31
Brief Summary
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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.
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Detailed Description
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The trial is designed to address the fundamental issue that in the diagnosis of latent tuberculosis (TB) infection, no gold standard exists. Thus, no existing test for latent TB is 100 % sensitive and specific - including the Tuberculin PPD RT23 SSI and QuantiFERON®-TB Gold In-Tube.
This will be addressed by evaluating C-Tb positive response rates in 4 groups defined by their estimated risk of infection with MTb. The groups will consist of paediatric and adult participants selected as being either occasional or close contacts to an active pulmonary TB case. In addition a group of confirmed TB cases and a group of participants with no history of exposure to MTb will be included as control groups.
50 participants in the negative control group will be tested with C-Tb alone in order to evaluate whether concomitant administration of C-Tb and Tuberculin PPD RT23 SSI could conceivably result in larger or smaller areas of induration to one or both tests as a result of expanding the clone of sensitised T-cells i.e. since Tuberculin PPD RT23 SSI includes among several other antigens ESAT-6 and CFP-10 and C-Tb also contains both these antigens.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
QUADRUPLE
Study Groups
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0.1 µg/0.1 mL C-Tb
The C-Tb and 2 T.U. Tuberculin PPD RT 23 SSI agents are given concomitantly to each volunteer in the RIGHT and LEFT forearms according to a double blind randomisation scheme
C-Tb
The C-Tb agent is administered by the Mantoux injection technique to each volunteer in the RIGHT or LEFT forearm according to a double blind randomisation scheme
2 T.U. Tuberculin PPD RT 23 SSI
The C-Tb and 2 T.U. Tuberculin PPD RT 23 SSI agents are given concomitantly to each volunteer in the RIGHT and LEFT forearms according to a double blind randomisation scheme
2 T.U. Tuberculin PPD RT 23 SSI
The 2 T.U. Tuberculin PPD RT 23 SSI agent is administered by the Mantoux injection technique to each volunteer in the RIGHT or LEFT forearm according to a double blind randomisation scheme
Interventions
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C-Tb
The C-Tb agent is administered by the Mantoux injection technique to each volunteer in the RIGHT or LEFT forearm according to a double blind randomisation scheme
2 T.U. Tuberculin PPD RT 23 SSI
The 2 T.U. Tuberculin PPD RT 23 SSI agent is administered by the Mantoux injection technique to each volunteer in the RIGHT or LEFT forearm according to a double blind randomisation scheme
Eligibility Criteria
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Inclusion Criteria
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
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
6 Weeks
65 Years
ALL
Yes
Sponsors
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Statens Serum Institut
OTHER
Responsible Party
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Principal Investigators
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Joan Cayla, MD
Role: PRINCIPAL_INVESTIGATOR
Public Health Agency of Barcelona
Henrik Aggerbeck, M. Sc.
Role: STUDY_CHAIR
Statens Serum Institut
Locations
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Hospital Universitario de Cruces
Barakaldo, Basque Country, Spain
CAP Drassanes, Unitat de Prevenció i Control de Tuberculosi
Barcelona, Catalonia, Spain
Hospital del Mar
Barcelona, Catalonia, Spain
Public Health Agency of Barcelona
Barcelona, Catalonia, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, Spain
Hospital Vall d'Hebron
Barcelona, Catalonia, Spain
Hospital Clínic i Provincial de Barcelona
Barcelona, Catalonia, Spain
Hospital Mutua de Terrassa
Barcelona, Catalonia, Spain
Hospital San Joan De Deu
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, Spain
Countries
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References
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Ruhwald M, Aggerbeck H, Gallardo RV, Hoff ST, Villate JI, Borregaard B, Martinez JA, Kromann I, Penas A, Anibarro LL, de Souza-Galvao ML, Sanchez F, Rodrigo-Pendas JA, Noguera-Julian A, Martinez-Lacasa X, Tunez MV, Fernandez VL, Millet JP, Moreno A, Cobos N, Miro JM, Roldan L, Orcau A, Andersen P, Cayla JA; TESEC Working Group. Safety and efficacy of the C-Tb skin test to diagnose Mycobacterium tuberculosis infection, compared with an interferon gamma release assay and the tuberculin skin test: a phase 3, double-blind, randomised, controlled trial. Lancet Respir Med. 2017 Apr;5(4):259-268. doi: 10.1016/S2213-2600(16)30436-2. Epub 2017 Feb 1.
Other Identifiers
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2011-005617-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
TESEC-06
Identifier Type: -
Identifier Source: org_study_id
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