Tuberculosis Clinical Trial
— TESEC-07Official title:
A Phase II/III Trial Investigating if Concomitant Injections of the Diagnostic Agents C-Tb and 2 T.U Tuberculin PPD RT 23 SSI Affect the Induration Responses in Combination With a Safety Assessment of C-Tb
Verified date | April 2015 |
Source | Statens Serum Institut |
Contact | n/a |
Is FDA regulated | No |
Health authority | South Africa: Medicines Control Council |
Study type | Interventional |
A new, more specific skin test to detect tuberculosis has been developed by Statens Serum
Institut in Denmark. The new skin test is named C-Tb and like the current Tuberculin a
positive test result will show as redness and/or induration at the injection site, while a
negative test will leave no reactions.
The aim of this study is to address if the size of induration and the sensitivity of C-Tb is
influenced by concomitant injections of C-Tb and Tuberculin. Furthermore, the intention is
to evaluate the safety of C-Tb when injected alone or concomitantly with Tuberculin.
Status | Completed |
Enrollment | 456 |
Est. completion date | September 2014 |
Est. primary completion date | September 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria (HIV Negative patients): - Has signed an informed consent - Aged 18 to 65 years - Has been diagnosed with active pulmonary TB: 1. has a compatible clinical picture of TB according to South African guidelines with the intention to treat and 1 documented positive culture result or 2. has a compatible clinical picture of TB according to South African Guidelines with the intention to treat and 1 documented positive GeneXpert analysis - Is HIV negative confirmed by 2 two rapid tests - Is willing and likely to comply with the trial procedures - Is prepared to grant authorized persons access to their medical record Inclusion Criteria (HIV Positive patients): - Has signed an informed consent - Aged 18-65 years - Has been diagnosed with active pulmonary TB: 1. has a compatible clinical picture of TB according to South African guidelines with the intention to treat and 1 documented positive culture result or 2. has a compatible clinical picture of TB according to South African Guidelines with the intention to treat and 1 documented positive GeneXpert analysis - Is HIV positive confirmed by: 1. 2 positive rapid tests or 2. 1 positive rapid tests and an additional confirmatory ELISA - A CD4 count has been performed - Is willing and likely to comply with the trial procedures - Is prepared to grant authorized persons access to their medical records Exclusion Criteria: - Has been in treatment for TB for more than 2 weeks - Has a known MDR/XDR-TB - 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 < 12 months prior to the day of inclusion - Is pregnant, breastfeeding or intending to get pregnant - Is a female of child bearing potential 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 current skin condition which interferes with the reading of the skin tests 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 patient, 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 study |
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 | TASK, M2, Karl Bremer Hospital, | Cape Town | |
South Africa | Tiervlei Trial Centre, Karl Bremer Hospital | Cape Town | |
South Africa | UCT Lung Institute | Cape Town | |
South Africa | Be Part Yoluntu Centre | Paarl | Western Cape |
South Africa | Primecure Medicentre | Port Elizabeth | |
South Africa | Setshaba Research Centre | Pretoria | |
South Africa | Synexus Stanza Bopape Clinic | Pretoria |
Lead Sponsor | Collaborator |
---|---|
Statens Serum Institut |
South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To compare the size of induration of C-Tb and PPD RT 23 if injected alone or concomitantly in Tuberculosis infected patients (HIV positives and HIV negatives) | Onset from the injection(s) to 28 days after the injections | No | |
Primary | To assess if concomitant injections of C-Tb and PPD RT 23 influence the tests abilities to identify positive results of Tuberculosis in Tuberculosis infected patients | Onset from the injection(s) to 28 days after the injections | No | |
Secondary | To compare the C-Tb test's ability to identify positive results in Tuberculosis infected patients with the in vitro QuantiFERON®TB Gold In Tube assay in blood collected immediately before application of the C-Tb skin test | Onset from the injection(s) to 28 days after the injections | No | |
Secondary | To compare the C-Tb test's ability to identify positive results in Tuberculosis infected patients with the PPD RT 23 test | Onset from the injection(s) to 28 days after the injections | No | |
Secondary | To assess the safety of C-Tb skin test by investigating laboratory safety parameters and assessing all adverse events (local and systemic) occurring within 28 days after administration of the C-Tb and/or PPD RT 23 tests | Onset from the injection(s) to 28 days after the injections | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05738681 -
Efficacy of N-acetylcysteine to Prevent Anti-tuberculosis Drug-induced Liver Injury: A Randomized Controlled Trial
|
Phase 2/Phase 3 | |
Recruiting |
NCT05526885 -
Tuberculosis Diagnostic Trial of CAD4TB Screening Alone Compared to CAD4TB Screening Combined With a CRP Triage Test, Both Followed by Confirmatory Xpert MTB/RIF Ultra in Communities of Lesotho and South Africa
|
N/A | |
Completed |
NCT04369326 -
Community Initiated Preventive Therapy for TB
|
N/A | |
Recruiting |
NCT04568967 -
TB-CAPT EXULTANT - HIV
|
N/A | |
Completed |
NCT02337270 -
Phase 1 Clinical Trial of the Safety and Immunogenicity of an Adenovirus-based TB Vaccine Administered by Aerosol
|
Phase 1 | |
Not yet recruiting |
NCT06253715 -
Shortened Regimen for Drug-susceptible TB in Children
|
Phase 3 | |
Recruiting |
NCT04271397 -
Immunological Biomarkers in Tuberculosis Management
|
N/A | |
Withdrawn |
NCT03639038 -
Tuberculosis Diagnosis by Flow Cytometry
|
||
Completed |
NCT03199313 -
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Sutezolid
|
Phase 1 | |
Recruiting |
NCT04975178 -
Efficacy, Safety and Immunogenicity Evaluation of MTBVAC in Newborns in Sub-Saharan Africa
|
Phase 3 | |
Completed |
NCT04463680 -
Rifampin and the Contraceptive Implant
|
Phase 4 | |
Completed |
NCT03973970 -
Assessing the Ability of the T-SPOT®.TB Test (IQ)
|
||
Recruiting |
NCT04230395 -
Alcohol Reduction Among People With TB and HIV in India
|
N/A | |
Completed |
NCT04874948 -
Absorption, Elimination and Safety of 14C-labeled Radioactive BTZ-043, a New Compound in TB Treatment
|
Phase 1 | |
Active, not recruiting |
NCT02906007 -
Evaluating the Pharmacokinetics, Safety, and Tolerability of Bedaquiline in Infants, Children, and Adolescents With Multidrug-Resistant Tuberculosis, Living With or Without HIV
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT05917210 -
Peer-led Implementation of TB-HIV Education and Adherence Counseling in Uganda
|
N/A | |
Not yet recruiting |
NCT05845112 -
Start Taking Action For TB Diagnosis
|
||
Not yet recruiting |
NCT06017843 -
Impact Evaluation of Use of MATCH AI Predictive Modelling for Identification of Hotspots for TB Active Case Finding
|
N/A | |
Active, not recruiting |
NCT02715271 -
Study of TB Lesions Obtained in Therapeutical Surgery
|
||
Completed |
NCT02781909 -
Potential Efficacy and Safety of Using Adjunctive Ibuprofen for XDR-TB Tuberculosis
|
Phase 2 |