| Methods | Randomized controlled trial Generation of allocation sequence: unclear Allocation concealment: central randomization Blinding: assessor only Inclusion of all randomized participants: 100% (10/10 and 12/12 in the rifampicin and rifabutin arms respectively) |
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| Participants | Number: 22 enrolled; number screened was not stated Inclusion criteria: tuberculosis patients with previously untreated disease; mycobacterial culture positive Exclusion criteria included alcoholism and psychological disturbance |
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| Interventions | 1. Rifabutin: 150 mg daily for 9 months 2. Rifampicin: 600 mg daily for 9 months Companion drugs: isoniazid (300 mg daily for 9 months) and ethambutol (20 mg/kg for 9 months) |
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| Outcomes | 1. Smear status at 2 months | |
| Notes | Location: multicentre trial at 2 sites in Poland (Warsaw and Lodz) Supervision: participants hospitalized for duration of their treatment Follow up: unclear how often sputum samples were collected Other: there was also an arm for participants who had previously received treatment, but this was uncontrolled HIV testing not carried out No power calculation was presented for the outcome measure |
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