TuberculosisPhase 3NCT01631266
Comparison of Diagnostic Performance of C-Tb to QuantiFERON®-TB, in Combination With a Safety Assessment of C-Tb vs Tuberculin PPD RT23 SSI
A Phase 3 study testing C-Tb and 2 T.U. Tuberculin PPD RT 23 SSI in people with Tuberculosis, run by Statens Serum Institut at 13 sites in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 weeks to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- C-Tb and 2 T.U. Tuberculin PPD RT 23 SSI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 979 participants
- Where
- 13 sitesSpain
- Study dates
- Jul 2012to Oct 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 weeks to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Can comply with one of the following groups:
- Negative control group: Must have no history of exposure to a TB index case, and have no signs or symptoms of TB
- Positive control group: Confirmed TB disease within the last 3 years by sputum smear microscopy and/or Culture, Gene Xpert or PCR
- 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
- Occasional contact group: Must be in contact with a pulmonary sputum smear positive TB index case between 6 hours/week and 6 hours/day
- Is between 6 weeks - 65 years of age
Show all 9Show fewer
- Participant, parent or legal guardian has provided signed informed consent
- Is willing and likely to comply with the trial procedures
- Is prepared to grant authorized persons access to their medical records
Who cannot join
- 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)
- Has been tuberculin tested less than 12 months prior to the day of inclusion
- Is pregnant, breastfeeding or intending to get pregnant within the trial period
- 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
- Has an active disease affecting the lymphoid organs except for HIV (e.g., Hodgkin's disease, lymphoma, leukaemia, sarcoidosis)
- 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
Show all 10Show fewer
- 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
- 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
- Has participated in previous clinical trials investigating injections with ESAT-6 and/or CFP-10 antigens
- Has a condition which in the opinion of the investigator is not suitable for participation in the trial
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Spain13 sites
Hospital Universitario de Cruces
Barakaldo, Basque Country, 48903
CAP Drassanes, Unitat de Prevenció i Control de Tuberculosi
Barcelona, Catalonia, 08001
Hospital del Mar
Barcelona, Catalonia, 08003
Public Health Agency of Barcelona
Barcelona, Catalonia, 08023
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, 08025
Hospital Vall d'Hebron
Barcelona, Catalonia, 08035
Hospital Clínic i Provincial de Barcelona
Barcelona, Catalonia, 08036
Hospital Mutua de Terrassa
Barcelona, Catalonia, 08221
Hospital San Joan De Deu
Barcelona, Catalonia, 08950
Hospital Universitario Lucus Augusti
Lugo, Galicia, 27004
Complexo Hospitalario de Pontevedra
Pontevedra, Galicia, 36071
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, Galicia, 15706
Complexo Hospitalario Universitario de Vigo
Vigo, Galicia, +34 981 950 036
About this study
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
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.
Read more
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.
Read the detailed description
The TESEC-06 trial is an open comparison of the diagnostics performance of C-Tb compared to QuantiFERON®-TB Gold In-Tube, in combination with a double-blind randomized split-body safety assessment of C-Tb versus Tuberculin PPD RT23 SSI.
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
- Tuberculosis
- Being tested
- C-Tb, 2 T.U. Tuberculin PPD RT 23 SSI
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-TbBiological
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 SSIBiological
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
| Study group | Role | What they receive |
|---|---|---|
| 0.1 µg/0.1 mL C-Tb | Experimental | 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 Receives: Biological: C-Tb |
| 2 T.U. Tuberculin PPD RT 23 SSI | Active comparator | 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 Receives: Biological: 2 T.U. Tuberculin PPD RT 23 SSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate an increasing trend in C-Tb test positivity across the four study groups, with 'positivity' defined as an induration ≥ 5 mm
Measured: Onset between the injections and 28 days after the injections
Secondary outcomes (19)
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
Measured: Onset between the injections and 28 days after the injections
To evaluate a possible trend in C-Tb induration diameters across the four pre-specified MTb infection risk sub-groups
Measured: Onset between the injections and 28 days after the injections
To evaluate a possible trend in PPD RT23 SSI induration diameters across the four pre-specified MTb infection risk sub-groups
Measured: Onset between the injections and 28 days after the injections
To evaluate a possible trend in QuantiFERON Gold In-Tube results across four pre-specified MTb infection risk sub-groups
Measured: On the day of the injections
To evaluate a possible trend in PPD RT23 SSI test positivity across four pre-specified MTb infection risk sub-groups
Measured: Onset between the injections and 28 days after the injections
To evaluate a possible trend in QuantiFERON Gold In-Tube test positivity across four pre-specified MTb infection risk sub-groups
Measured: On the day of the injections
To evaluate the difference in sensitivity between C-Tb and QuantiFERON Gold In-Tube in the positive control group
Measured: From the day of injections to 2-3 days after the injections
To evaluate the difference in specificity between C-Tb and QuantiFERON Gold In-Tube in the negative control group
Measured: From the day of injections to 2-3 days after the injections
To evaluate the difference in sensitivity between C-Tb and PPD RT23 SSI in positive control group
Measured: Onset between the injections and 28 days after the injections
To evaluate the difference in specificity between C-Tb and PPD RT23 SSI in the negative control group
Measured: Onset between the injections and 28 days after the injections
To compare the size of induration of C-Tb if injected alone or concomitantly with PPD RT23 SSI in negative control group
Measured: Onset between the injections and 28 days after the injections
To compare the specificity of C-Tb if injected alone or concomitantly with PPD RT23 SSI, in the negative control group
Measured: Onset between the injections and 28 days after the injections
To compare the diagnostic outcome of C-Tb to that of QuantiFERON Gold In-Tube using a latent class approach
Measured: From the day of injections to 2-3 days after the injections
To compare the diagnostic outcome of C-Tb to that of PPD RT23 SSI using a latent class approach
Measured: Onset between the injections and 28 days after the injections
To evaluate the secondary analyses above (1-14) of C-Tb and PPD RT23 SSI using alternative cut-off values
Measured: Onset between the injections and 28 days after the injections
To compare the diagnostic outcome of C-Tb and QuantiFERON Gold In-Tube stratified on the four study groups
Measured: From the day of injections to 2-3 days after the injections
To compare the diagnostic outcome of C-Tb and PPD RT23 SSI stratified on the four study groups
Measured: Onset between the injections and 28 days after the injections
To evaluate the clinical safety of C-Tb
Measured: Onset between the injections and 28 days after the injections
To evaluate the clinical safety of PPD RT23 SSI
Measured: Onset between the injections and 28 days after the injections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2012 (estimated)
- Study startJul 2012
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 979 participants (actual)
Sponsor and investigators
- Lead sponsor
- Statens Serum Institut
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joan Cayla, MD, Principal investigator, Public Health Agency of BarcelonaHenrik Aggerbeck, M. Sc., Study chair, Statens Serum Institut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01631266
- Sponsor's protocol ID
- TESEC-06
- Other IDs
- 2011-005617-36
- Status last verified
- Apr 2015
- First submitted
- 28 Jun 2012
- Last updated
- 17 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28159608
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01631266
- Acronym / sponsor ID
- TESEC-06
- Conditions
- Tuberculosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 979 participants (actual)
- Lead sponsor
- Statens Serum InstitutUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 29 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The TESEC-06 trial is an open comparison of the diagnostics performance of C-Tb compared to QuantiFERON®-TB Gold In-Tube, in combination with a double-blind randomized split-body safety assessment of C-Tb versus Tuberculin PPD RT23 SSI.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.1 µg/0.1 mL C-Tb | Experimental | Biological: C-TbThe 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 | Active comparator | Biological: 2 T.U. Tuberculin PPD RT 23 SSIThe 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 |
Who may qualify
- Ages
- 6 weeks to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Can comply with one of the following groups:
- Is between 6 weeks - 65 years of age
- Participant, parent or legal guardian has provided signed informed consent
- Is willing and likely to comply with the trial procedures
- Is prepared to grant authorized persons access to their medical records
Key exclusion criteria (10 listed)
- 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)
- Has been tuberculin tested less than 12 months prior to the day of inclusion
- Is pregnant, breastfeeding or intending to get pregnant within the trial period
- 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
- Has an active disease affecting the lymphoid organs except for HIV (e.g., Hodgkin's disease, lymphoma, leukaemia, sarcoidosis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C-TbThe 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 | Biological | 0.1 µg/0.1 mL C-Tb |
| 2 T.U. Tuberculin PPD RT 23 SSIThe 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 | Biological | 2 T.U. Tuberculin PPD RT 23 SSI |
Primary outcome
To demonstrate an increasing trend in C-Tb test positivity across the four study groups, with 'positivity' defined as an induration ≥ 5 mm
Time frame: Onset between the injections and 28 days after the injections
19 secondary outcomes
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
Time frame: Onset between the injections and 28 days after the injections
To evaluate a possible trend in C-Tb induration diameters across the four pre-specified MTb infection risk sub-groups
Time frame: Onset between the injections and 28 days after the injections
To evaluate a possible trend in PPD RT23 SSI induration diameters across the four pre-specified MTb infection risk sub-groups
Time frame: Onset between the injections and 28 days after the injections
To evaluate a possible trend in QuantiFERON Gold In-Tube results across four pre-specified MTb infection risk sub-groups
Time frame: On the day of the injections
To evaluate a possible trend in PPD RT23 SSI test positivity across four pre-specified MTb infection risk sub-groups
Time frame: Onset between the injections and 28 days after the injections
To evaluate a possible trend in QuantiFERON Gold In-Tube test positivity across four pre-specified MTb infection risk sub-groups
Time frame: On the day of the injections
To evaluate the difference in sensitivity between C-Tb and QuantiFERON Gold In-Tube in the positive control group
Time frame: From the day of injections to 2-3 days after the injections
To evaluate the difference in specificity between C-Tb and QuantiFERON Gold In-Tube in the negative control group
Time frame: From the day of injections to 2-3 days after the injections
To evaluate the difference in sensitivity between C-Tb and PPD RT23 SSI in positive control group
Time frame: Onset between the injections and 28 days after the injections
To evaluate the difference in specificity between C-Tb and PPD RT23 SSI in the negative control group
Time frame: Onset between the injections and 28 days after the injections
To compare the size of induration of C-Tb if injected alone or concomitantly with PPD RT23 SSI in negative control group
Time frame: Onset between the injections and 28 days after the injections
To compare the specificity of C-Tb if injected alone or concomitantly with PPD RT23 SSI, in the negative control group
Time frame: Onset between the injections and 28 days after the injections
To compare the diagnostic outcome of C-Tb to that of QuantiFERON Gold In-Tube using a latent class approach
Time frame: From the day of injections to 2-3 days after the injections
To compare the diagnostic outcome of C-Tb to that of PPD RT23 SSI using a latent class approach
Time frame: Onset between the injections and 28 days after the injections
To evaluate the secondary analyses above (1-14) of C-Tb and PPD RT23 SSI using alternative cut-off values
Time frame: Onset between the injections and 28 days after the injections
To compare the diagnostic outcome of C-Tb and QuantiFERON Gold In-Tube stratified on the four study groups
Time frame: From the day of injections to 2-3 days after the injections
To compare the diagnostic outcome of C-Tb and PPD RT23 SSI stratified on the four study groups
Time frame: Onset between the injections and 28 days after the injections
To evaluate the clinical safety of C-Tb
Time frame: Onset between the injections and 28 days after the injections
To evaluate the clinical safety of PPD RT23 SSI
Time frame: Onset between the injections and 28 days after the injections
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2015.
- Derived from this study: PubMed 28159608Ruhwald 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joan Cayla, MD principal investigator
Public Health Agency of Barcelona
Henrik Aggerbeck, M. Sc. study chair
Statens Serum Institut
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing C-Tb and 2 T.U. Tuberculin PPD RT 23 SSI in people with Tuberculosis, run by Statens Serum Institut at 13 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To demonstrate an increasing trend in C-Tb test positivity across the four study groups, with 'positivity' defined as an induration ≥ 5 mm (time frame: Onset between the injections and 28 days after the injections). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01631266, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2015.