TuberculosisPhase 3NCT01642888
A Trial in Subjects Suspected to Have Tuberculosis, Comparing the Diagnostic Performance of C-Tb to QuantiFERON®, in Combination With a Safety Assessment of C-Tb Versus 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 9 sites in South Africa.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 28 days 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
- 1,190 participants
- Where
- 9 sitesSouth Africa
- Study dates
- Sep 2012to Sep 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 28 days to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- HIV NEGATIVE PARTICIPANTS:
- Participants between 5 and 65 years attending the TB clinic due to suspicion of TB disease
- 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)
- Is between 28 days and 65 years of age
- Participant, parent or legal guardian has signed the informed consent
- 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
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- Is willing and likely to comply with the trial procedures
- Is prepared to grant authorized persons access to their medical record
- HIV POSITIVE PARTICIPANTS:
- Participants between 5 and 65 years attending the TB clinic due to suspicion of TB disease
- 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)
- Is between 28 days and 65 years of age
- Participant, parent or legal guardian has signed the informed consent
- Is HIV positive confirmed by:
- two positive rapid tests or
- 1 positive rapid test and an additional confirmatory ELISA test
- A CD4 count has been done
- Is willing and likely to comply with the trial procedures
- Is prepared to grant authorized persons access to their medical record
- HIV NEGATIVE CONTROL GROUP:
- Participant with no known contact to people infected with MTb and no signs or symptoms of TB.
- Is between 5 and 11 years of age
- Participant, parent or legal guardian has signed the informed consent
- Is HIV negative confirmed by two rapid tests
- Is willing and likely to comply with the trial procedures
- Is prepared to grant authorized persons access to their medical record
Who cannot join
- HIV NEGATIVE PARTICIPANTS:
- Has a confirmed diagnosis of tuberculosis at Screening Visit
- 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
- Has been tuberculin (TST) tested less than 12 months prior to the day of inclusion
- Is pregnant, breastfeeding or intending to get pregnant during the trial period
- 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
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- Has an active disease affecting the lymphoid organs (e.g., Hodgkin's disease, lymphoma, leukaemia, sarcoidosis)
- 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
- 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
- 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
- Has participated in previous clinical trials investigating the 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
- HIV POSITIVE PARTICIPANTS:
- Has a confirmed diagnosis of tuberculosis at Screening Visit
- Has been vaccinated with a live vaccine within 6 weeks prior to the day of inclusion (e.g. MMR, yellow fever, oral typhoid vaccines)
- Has been tuberculin (TST) tested less than 12 months prior to the day of inclusion
- Is pregnant, breastfeeding or intending to get pregnant during the trial period
- 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
- Has an active disease affecting the lymphoid organs except for HIV (e.g., Hodgkin's disease, lymphoma, leukaemia, sarcoidosis)
- Has a known diagnosis of AIDS or is receiving antiviral therapy at the time of Screening Visit
- 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
- 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
- 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
- Has participated in previous clinical trials investigating the 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
- HIV NEGATIVE CONTROL GROUP:
- 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
- Has been tuberculin (TST) tested less than 12 months prior to the day of inclusion
- Has an active disease affecting the lymphoid organs (e.g., Hodgkin's disease, lymphoma, leukaemia, sarcoidosis)
- 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
- 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
- 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
- Has participated in previous clinical trials investigating the 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
9 sites in 1 country.
9 sites in 1 country
South Africa9 sites
M2 Karl Bremer Hospital
Bellville, Cape Town, Western Cape, 7530
Tiervlei Trial Centre, Karl Bremer Hospital
Bellville, Cape Town, Western Cape, 7530
Worthwhile Clinical Trials, Lakeview Hospital
Benoni, Gauteng, 1501
UCT Lung Institute, Groote Schuur Hospital
Cape Town, Western Cape, 7925
Be Part Yoluntu Centre
Paarl, Western Cape, 7626
Primecure Medicentre, Mercantile Hospital
Port Elizabeth, Eastern Cape, 6014
Synnyside Medi-Clinic
Pretoria, Gauteng, 0002
Synexus Stanza Bopape Clinic
Pretoria, Gauteng, 0122
Setshaba Research Centre
Pretoria, Gauteng, 0152
About this study
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)
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.
Read more
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.
Read the detailed description
The TESEC-05 trial is an open comparison of the diagnostics performance of C-Tb compared to the QuantiFERON®-TB Gold In-Tube, in combination with a double-blind randomized split-body safety assessment of C-Tb versus to 2 T.U. Tuberculin PPD RT23 SSI.
The trial is a multi-centre Phase III clinical trial designed specifically to address C-Tb in relation to the paediatric population and to HIV infection. The intention is to evaluate how the C-Tb test performs in the paediatric population with respect to safety, and to ensure that SSI will be able to extrapolate data obtained in an adult population to the paediatric population.
Furthermore, the intention is both to evaluate the diagnostic performance and safety of C-Tb in HIV infected individuals and to evaluate whether SSI will be able to extrapolate data obtained in a non-HIV population to a HIV population.
The trial population will consist of paediatric participants with suspected TB infection and adult participants suspected to have TB disease. Furthermore a control group of 100 children between 5 - 11 years of age with no symptoms or known exposure will be recruited from an area with a "low" prevalence of TB (an area with an incidence rate < 299/100,000 per year, the average rate of TB in South Africa in 2005 was 645/100,000 per year.
The trial will be conducted in South Africa where the prevalence of HIV infection is high and MTb infections are endemic.
BCG vaccination at birth has been common practice since 1961 in South Africa. Thus most of the participants are presumed BCG vaccinated.
- 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 evaluate the diagnostic performance of C-Tb in relation to age, HIV and CD4 counts
Measured: Onset between the injections and 28 days after the injections
To evaluate the clinical safety of C-Tb, with emphasis on children and HIV positive participants
Measured: Onset between the injections and 28 days after the injections
Secondary outcomes (9)
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.
Measured: From injections to 2-3 days after the injections
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.
Measured: Onset between the injections and 28 days after the injections
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.
Measured: From injections to 2-3 days after the injections
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.
Measured: Onset between the injections and 28 days after the injections
To compare the diagnostic outcome of C-Tb to that of QuantiFERON®-TB Gold in-Tube using a latent class approach
Measured: From injections to 2-3 days after the injections
To compare the diagnostic outcome of C-Tb to that of Tuberculin PPD RT23 SSI using a latent class approach
Measured: Onset between the injections and 28 days after the injections
To evaluate the diagnostic performance of Tuberculin PPD RT23 SSI in relation to age, HIV status and CD4 counts
Measured: Onset between the injections and 28 days after the injections
To evaluate the clinical safety of Tuberculin PPD RT23 SSI
Measured: Onset between the injections and 28 days after the injections
To evaluate the diagnostic performance of QuantiFERON®-TB Gold in-Tube in relation to age, HIV status and CD4 counts
Measured: On the day of the injections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2014
- Study completionSep 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
- 1,190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Statens Serum Institut
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas Diacon, MD, Principal investigator, M2 Karl Bremer HospitalHenrik Aggerbeck, M.Sc., Study chair, Statens Serum Institut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01642888
- Sponsor's protocol ID
- TESEC-05
- Other IDs
- 2011-005078-40
- Status last verified
- Apr 2016
- First submitted
- 5 Jul 2012
- Last updated
- 14 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Aggerbeck H, Ruhwald M, Hoff ST, Borregaard B, Hellstrom E, Malahleha M, Siebert M, Gani M, Seopela V, Diacon A, Lourens M, Andersen P, Dheda K. C-Tb skin test to diagnose Mycobacterium tuberculosis infection in children and HIV-infected adults: A phase 3 trial. PLoS One. 2018 Sep 24;13(9):e0204554. doi: 10.1371/journal.pone.0204554. eCollection 2018.
PubMed 30248152
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01642888
- Acronym / sponsor ID
- TESEC-05
- Conditions
- Tuberculosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,190 participants (actual)
- Lead sponsor
- Statens Serum InstitutUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 17 Jul 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 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.
Detailed description
The TESEC-05 trial is an open comparison of the diagnostics performance of C-Tb compared to the QuantiFERON®-TB Gold In-Tube, in combination with a double-blind randomized split-body safety assessment of C-Tb versus to 2 T.U. Tuberculin PPD RT23 SSI.
The trial is a multi-centre Phase III clinical trial designed specifically to address C-Tb in relation to the paediatric population and to HIV infection. The intention is to evaluate how the C-Tb test performs in the paediatric population with respect to safety, and to ensure that SSI will be able to extrapolate data obtained in an adult population to the paediatric population.
Furthermore, the intention is both to evaluate the diagnostic performance and safety of C-Tb in HIV infected individuals and to evaluate whether SSI will be able to extrapolate data obtained in a non-HIV population to a HIV population.
The trial population will consist of paediatric participants with suspected TB infection and adult participants suspected to have TB disease. Furthermore a control group of 100 children between 5 - 11 years of age with no symptoms or known exposure will be recruited from an area with a "low" prevalence of TB (an area with an incidence rate < 299/100,000 per year, the average rate of TB in South Africa in 2005 was 645/100,000 per year.
The trial will be conducted in South Africa where the prevalence of HIV infection is high and MTb infections are endemic.
BCG vaccination at birth has been common practice since 1961 in South Africa. Thus most of the participants are presumed BCG vaccinated.
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
- 28 days to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (26 listed)
- Participants between 5 and 65 years attending the TB clinic due to suspicion of TB disease
- 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)
- Is between 28 days and 65 years of age
- Participant, parent or legal guardian has signed the informed consent
- 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
Key exclusion criteria (34 listed)
- Has a confirmed diagnosis of tuberculosis at Screening Visit
- 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
- Has been tuberculin (TST) tested less than 12 months prior to the day of inclusion
- Is pregnant, breastfeeding or intending to get pregnant during the trial period
- 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
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 evaluate the diagnostic performance of C-Tb in relation to age, HIV and CD4 counts
Time frame: Onset between the injections and 28 days after the injections
To evaluate the clinical safety of C-Tb, with emphasis on children and HIV positive participants
Time frame: Onset between the injections and 28 days after the injections
9 secondary outcomes
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.
Time frame: From injections to 2-3 days after the injections
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.
Time frame: Onset between the injections and 28 days after the injections
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.
Time frame: From injections to 2-3 days after the injections
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.
Time frame: Onset between the injections and 28 days after the injections
To compare the diagnostic outcome of C-Tb to that of QuantiFERON®-TB Gold in-Tube using a latent class approach
Time frame: From injections to 2-3 days after the injections
To compare the diagnostic outcome of C-Tb to that of Tuberculin PPD RT23 SSI using a latent class approach
Time frame: Onset between the injections and 28 days after the injections
To evaluate the diagnostic performance of Tuberculin PPD RT23 SSI in relation to age, HIV status and CD4 counts
Time frame: Onset between the injections and 28 days after the injections
To evaluate the clinical safety of Tuberculin PPD RT23 SSI
Time frame: Onset between the injections and 28 days after the injections
To evaluate the diagnostic performance of QuantiFERON®-TB Gold in-Tube in relation to age, HIV status and CD4 counts
Time frame: On the day of 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 14 Apr 2016.
- Derived from this study: PubMed 30248152Aggerbeck H, Ruhwald M, Hoff ST, Borregaard B, Hellstrom E, Malahleha M, Siebert M, Gani M, Seopela V, Diacon A, Lourens M, Andersen P, Dheda K. C-Tb skin test to diagnose Mycobacterium tuberculosis infection in children and HIV-infected adults: A phase 3 trial. PLoS One. 2018 Sep 24;13(9):e0204554. doi: 10.1371/journal.pone.0204554. eCollection 2018.
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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.
Andreas Diacon, MD principal investigator
M2 Karl Bremer Hospital
Henrik Aggerbeck, M.Sc. study chair
Statens Serum Institut
9 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 9 sites in South Africa.
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 26 inclusion and 34 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 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in South Africa. 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 evaluate the diagnostic performance of C-Tb in relation to age, HIV and CD4 counts (time frame: Onset between the injections and 28 days after the injections). The study lists 2 primary outcomes in all. 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 NCT01642888, 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 14 Apr 2016.