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This is a Phase IIa, open-label, randomized study in treatment-naïve, sputum smear-positive patients with drug-sensitive pulmonary TB to assess the early bactericidal activity of telacebec (Q203).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telacebec (Q203) tablet | Experimental |
| |
| Rifafour e-275 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telacebec (Q203) | Drug | High, Mid, Low dose of telacebec |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The EBA (early bactericidal activity) of telacebec (Q203) | The EBA determined by the rate of change in the time to positivity (TTP) in sputum over the periods Days 0 to 14 | Days 0 to 14 post dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TASK Applied Science | Cape Town | South Africa | ||||
| UCT Lung Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40116781 | Derived | Janssen S, Upton C, de Jager VR, van Niekerk C, Dawson R, Hutchings J, Kim J, Choi J, Nam K, Sun E, Diacon AH. Telacebec, a Potent Agent in the Fight against Tuberculosis: Findings from a Randomized, Phase 2 Clinical Trial and Beyond. Am J Respir Crit Care Med. 2025 Aug;211(8):1504-1512. doi: 10.1164/rccm.202408-1632OC. |
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| Rifafour e-275 |
| Drug |
RHZE (R=rifampicin: H=isoniazid: Z=pyrazinamide: E=ethambutol) |
|
| Cape Town |
| South Africa |
| ID | Term |
|---|---|
| C584497 | telacebec |
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