Accuracy of Two Novel Tuberculosis-specific Skin Tests in Diagnosing Tuberculosis Infectio
- Registration Number
- TCTR20230526003
- Lead Sponsor
- Health Systems Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 305
1.1.1. For microbiologically-confirmed TB participants
1)Male or female subject aged 18-65 years or older.
2)Medically diagnosed with TB within the last 6 months (confirmed through cultures and/or molecular testing) and undergoing treatment with anti-tuberculosis agents.
3)Capable of comprehending (speaking, reading, and/or writing) Thai.
4)Capable of attending all study visits according to the study schedule.
5)Willing to provide written inform consent before any study procedures.
1.1.2. For participants with low risk of TB-infection
1)Male or female subject aged 18-65 years or older.
2)No history of contracting TB or contact with patients infected with TB.
3)Capable of comprehending (speaking, reading, and/or writing) Thai.
4)Capable of attending all study visits according to the study schedule.
5)Willing to provide written inform consent before any study procedures.
1.1.3. For participants with high risk of TB-infection
1)Male or female subject aged 18-65 years or older.
2)Living with pulmonary TB positive patients, in contact with TB positive patients >120 hours/month, or in contact with TB positive patients >8 hours in a single sitting.
3)Capable of comprehending (speaking, reading, and/or writing) Thai.
4)Capable of attending all study visits according to the study schedule.
5)Willing to provide written inform consent before any study procedures.
For microbiologically-confirmed TB participants
1)Immunodeficient; chemotherapy or immunosuppressant medication use within a year of screening (excludes HIV positive patients with CD4 more than 200 cells/mm3 and viral suppression at least 6 months prior to screening and enrollment).
2)TST at least 12 months prior to enrolling in the clinical trial
3)Pregnant or lactating (for biological female subjects)
4)History of skin disease(s), tattoos, or scarring in regions where the device(s) will be administered (potentially hindering their efficacy and interpretations of results).
1.2.2. For participants with low risk of TB-infection
1)Has a history of TB infection, manifestation of, or thoracic X-ray with TB-related symptoms.
2)Immunodeficient; chemotherapy or immunosuppressant medication use within a year of screening (excludes HIV positive patients with CD4 more than 200 cells/mm3 and viral suppression at least 6 months prior to screening and enrollment).
3)TST at least 12 months prior to enrolling in the clinical trial.
4)Pregnant or lactating (for biological female subjects).
5)History of skin disease(s), tattoos, or scarring in regions where the device(s) will be administered (potentially hindering their efficacy and interpretations of results).
1.2.3. For participants with high risk of TB-infection
1)Had a history of TB infection or manifestation of TB-related symptoms.
2)Immunodeficient; chemotherapy or immunosuppressant medication use within a year of screening (excludes HIV positive patients with CD4 more than 200 cells/mm3 and viral suppression at least 6 months prior to screening and enrollment).
3)TST at least 12 months prior to enrolling in the clinical trial.
4)Pregnant or lactating (for biological female subjects).
5)History of skin disease(s), tattoos, or scarring in regions where the device(s) will be administered (potentially hindering their efficacy and interpretations of results).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sensitivity, Specificity, and Likelihood ratios of C-Tb and C-TST with microbiologically-confirmed TB as standard. at 48-72 h after TB skin test Skin Assessment
- Secondary Outcome Measures
Name Time Method Sensitivity, Specificity, and Likelihood ratios of C-Tb and C-TST with IGRA as reference standard. at 48-72 h after TB skin test Skin Assessment,Reliability of the inter-observer variation to determine TB infection using each test. at 48-72 h after TB skin test Cohen's Kappa coefficient