TBTC Study 29: Rifapentine During Intensive Phase Tuberculosis (TB) Treatment
第2相
完了
NCT00694629
| 対象疾患 | Pulmonary Tuberculosis |
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| 相 | 第2相 |
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| スポンサー | Centers for Disease Control and Prevention |
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| ステータス | 完了 |
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| 参加者数 | 334 名 |
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| 介入（薬剤） | rifapentine, rifapentine 10 mg/kg, rifapentine 15 mg/kg, rifapentine 20 mg/kg |
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| 開始日 | 2008年12月 |
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| 完了日 | 2013年6月 |
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| 結果公開日 | 2026年7月23日 |
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概要
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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すべての治験
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