| Methods | Randomized controlled trial Generation of allocation sequence: unclear Allocation concealment: unclear Blinding: assessor only Inclusion of all randomized participants: 88% (154/175) for rifampicin, 94.8% (165/174) for rifabutin 150 mg, and 86.5% (148/171) for rifabutin 300 mg at 6 months; 70.9% (124/175) for rifampicin, 74.1% (129/174) for rifabutin 150 mg, and 73.7% (126/171) for rifabutin 300 mg |
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| Participants | Number: 520 enrolled; number screened for entry not reported Inclusion criteria: tuberculosis patients with previously untreated disease; HIV serology negative; Mycobacterial culture positive on 2 separate occasions |
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| Interventions | 1. Rifabutin: 150 mg daily for 6 months 2. Rifabutin: 300 mg daily for 6 months 3. Rifampicin: 600 mg daily for 6 months Dose was not adjusted for weight Companion drugs: isoniazid (300 mg daily for 6 months); ethambutol (25 mg/kg daily for 2 months); and pyrazinamide (30 mg/kg daily for 2 months) |
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| Outcomes | 1. "Conversion of sputum bacterial cultures" at weeks 12 and 24 (composite primary outcome measure) 2. Relapse (over 24 months) 3. Time to sputum culture conversion | |
| Notes | Location: multicentre study at 1 site in Argentina, 3 sites in Brazil, and 2 sites in Thailand Supervision: participants hospitalized for the first 2 months Follow up: sputum collected every 2 weeks during the initial phase of therapy, 89% follow up at 6 months, and 68% at 30 months; only 75% complete at the time of the available trial No power calculation was presented for any outcome measure |
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