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| Name | Class |
|---|---|
| Respiratory Programmatic Implementation and Research Institute (RPRI) | UNKNOWN |
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This is an operational research in household/close contacts of confirmed TB patients to evaluate the effectiveness of C-TST compared to IGRA test in identifying latent TB cases using parameters of effectiveness and safety.
The study is designed as an operational research. After informed consent and screening by evaluation of medical history followed by thorough physical examination and vital signs test (body temperature, blood pressure, pulse rate, and respiration rate) and urine pregnancy test for women of childbearing potential, blood collection will be done in 300 eligible subjects for IGRA test, followed by C-TST skin test. Measure the body temperature of all subjects 30 min after the skin test. Test results will be observed with skin reaction at the injection site 48~72 h after the skin test. Test results along with presence of adverse events until 7 days follow-up will be recorded. If there are discrepancies in the test result, a T-SPOT test will be conducted after the skin test.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic Testing Arm | Experimental | The study was a prospective, open-label, non-randomized study. All subjects underwent IGRA testing (QFT), followed by C-TST administration. T-SPOT.TB tests were performed only in cases of any discrepancies in the results between C-TST and QFT and were used as part of a composite reference standard. Subjects then underwent blood collection (6 mL venous blood) using lithium-heparin tube for IGRA Quantiferon® testing, followed by administration of 0.1 mL 5 U C-TST intradermally on the palm side of the forearm using Mantoux method on Day 1. Blood collection and administration of C-TST were performed by an authorized site nurse from each site. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Mycobacterium Tuberculosis Fusion Protein Tuberculin Skin Test (C-TST) | Drug | The study was a prospective, open-label, non-randomized study. All subjects underwent IGRA testing (QFT), followed by C-TST administration. T-SPOT.TB tests were performed only in cases of any discrepancies in the results between C-TST and QFT and were used as part of a composite reference standard. Subjects then underwent blood collection (6 mL venous blood) using lithium-heparin tube for IGRA Quantiferon® testing, followed by administration of 0.1 mL 5 U C-TST intradermally on the palm side of the forearm using Mantoux method on Day 1. Blood collection and administration of C-TST were performed by an authorized site nurse from each site. |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptance rate between C-TST and IGRA test in identifying latent TB infection in household and close contact populations. | The primary outcome is the concordance between C-TST and QuantiFERON-TB (QFT) results. All subjects underwent QFT testing followed by 0.1 mL 5 U C-TST administered intradermally on the forearm using the Mantoux method. In cases of discrepant results between C-TST and QFT, T-SPOT.TB testing was performed as part of a composite reference standard. Concordance will be calculated based on agreement rates between the tests. | 7 days after the skin test |
| Measure | Description | Time Frame |
|---|---|---|
| Safety endpoints: Incidence of all AEs within 7 days after skin test injection. |
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Inclusion Criteria:
Exclusion Criteria:
Participants must self-identify as the gender corresponding to their biological sex at birth.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RSUP Persahabatan (Persahabatan General Hospital) | Jakarta | Jakarta Timur (East Jakarta) | 13220 | Indonesia |
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| ID | Term |
|---|---|
| D055985 | Latent Tuberculosis |
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| within 7 days after the skin test |
| Incremental Cost Effectiveness Ratio | On the third visit, subjects will be asked to fill out an acceptability questionnaire. In additional to assess cost-effectiveness, investigator will use primary data obtained from health workers (doctors, nurses, and laboratory workers) as well as cost summary used in laboratories. Other data will be obtained from secondary data and model assumptions. | Day 7 after skin test |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D000085343 | Latent Infection |