| Methods | Randomized controlled trial Generation of allocation sequence: unclear Allocation concealment: unclear Blinding: assessor only Inclusion of all randomized participants: 75.6% (118/156) for rifampicin and 75.4% (107/142) for rifabutin at 6 months; and 32.1% (50/156) for rifampicin and 32.4% (46/142) for rifabutin at 30 months |
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| Participants | Number enrolled: 298; number screened for entry was not reported Inclusion criteria: tuberculosis patients with previously untreated disease; Mycobacterial culture positive |
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| Interventions | 1. Rifabutin: 300 mg daily for 2 months then twice weekly for 4 months 2. Rifampicin: 600 mg daily for 2 months then twice weekly for 4 months Dose was not adjusted for weight Companion drugs: isoniazid (400 mg daily for 2 months then 600 mg twice weekly for 4 months); ethambutol (1200 mg daily for 2 months then 2400 mg twice weekly for 4 months); and pyrazinamide (2 g daily for 2 months) |
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| Outcomes | 1. "Bacteriological conversion at weeks 8, 12 and 24" (composite primary outcome measure) 2. Relapse (over 24 months) 3. Time to sputum culture conversion | |
| Notes | Location: multicentre study at 8 sites in South Africa Supervision: ambulatory treatment from start was permitted, but most patients hospitalized were for 6 months Follow up: sputum collected every 2 weeks during initial phase of therapy; follow up was 75% at 6 months and 30% at 30 months HIV testing not carried out No power calculation was presented for any outcome measure |
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