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. 2007 Oct 17;2007(4):CD005159. doi: 10.1002/14651858.CD005159.pub2
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
Participants Number enrolled: 298; number screened for entry was not reported
Inclusion criteria: tuberculosis patients with previously untreated disease; Mycobacterial culture positive
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)
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