TBTC Study 29: Rifapentine During Intensive Phase Tuberculosis (TB) Treatment
Фаза 2
Завершено
NCT00694629
| Заболевание | Pulmonary Tuberculosis |
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| Фаза | Фаза 2 |
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| Спонсор | Centers for Disease Control and Prevention |
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| Статус | Завершено |
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| Участники | 334 участн. |
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| Вмешательство | rifapentine, rifapentine 10 mg/kg, rifapentine 15 mg/kg, rifapentine 20 mg/kg |
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| Дата начала | 12.2008 |
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| Дата завершения | 06.2013 |
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| Публикация результатов | 23.07.2026 |
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Кратко
This Phase 2, multicenter, open-label clinical trial evaluated the antimicrobial activity and safety of rifapentine-containing regimens during the intensive phase of pulmonary tuberculosis treatment. Participants were randomized to receive either a standard rifampin-based regimen (RHZE) or a rifapentine-substituted regimen (PHZE). An extension study evaluated higher daily doses of rifapentine (10, 15, and 20 mg/kg). The primary endpoint was sputum culture conversion at 8 weeks. Secondary outcomes included time to culture conversion, safety, and treatment discontinuation.
Participants With Negative Sputum Culture at 8 Weeks
8 weeks. · participants
| Standard Intensive-Phase TB Treatment: Rifampin (10 mg/kg) + Isoniazid + Pyrazinamide + Ethambutol | 52 participants |
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| lRifapentine 10 mg/kg TB Treatment (PHZE): Isoniazid + Pyrazinamide + Ethambutol | 62 participants |
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| Rifapentine 15 mg/kg TB Treatment (PHZE): Isoniazid + Pyrazinamide + Ethambutol | 59 participants |
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| Rifapentine 20 mg/kg TB Treatment (PHZE): Isoniazid + Pyrazinamide + Ethambutol | 54 participants |
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Participants Who Discontinued Treatment During Intensive Phase
8 weeks · participants
| Standard Intensive-Phase TB Treatment: Rifampin (10 mg/kg) + Isoniazid + Pyrazinamide + Ethambutol | 11 participants |
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| lRifapentine 10 mg/kg TB Treatment (PHZE): Isoniazid + Pyrazinamide + Ethambutol | 5 participants |
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| Rifapentine 15 mg/kg TB Treatment (PHZE): Isoniazid + Pyrazinamide + Ethambutol | 5 participants |
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| Rifapentine 20 mg/kg TB Treatment (PHZE): Isoniazid + Pyrazinamide + Ethambutol | 9 participants |
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