Galli [9] | Children (aged <18 years) with LTBI Daily 9H (n=264) versus daily 3RH (n=220) | Retrospective study | Adverse effects | 3RH 1/220 (0.45%) versus 9H 5/264 (1.9%); p=0.3 | 0.24 (0.03–2.04) |
Spyridis [10] | Children (aged <15 years) with LTBI Period 1: 1995–1998 Daily 9H (n=232) versus daily 4RH (n=238) 7–11-year follow-up Period 2: 1999–2002 Daily 4RH (n=236) versus daily 3RH (n=220) 3–7-year follow-up | Prospective randomised controlled trial | Treatment compliance | Period 1: 4RH (92%) versus 9H (86%); p=0.011 Period 2: No significant difference in compliance for 3RH versus 4RH; p=0.510 | 1.07 (1.01–1.14) |
Drug adverse effects | GI: 6.5% 9H versus 0.7% 4RH; p<0.0001 Transient increase in liver enzymes: 6% 9H versus 1.2% RH; p<0.0001 In RH group 1.3% rash and 0.7% photosensitivity Treatment discontinuation due to adverse events was none in both groups | 0.332 (0.197–0.559) |
Treatment efficacy | Proportion of compliant patients who developed chest radiograph changes suggestive of active tuberculosis: 24% 9H versus 11.8% 4RH; p<0.0001 13.6% 4RH versus 11% 3RH; p=0.079 No clinical disease observed in either group | 0.492 (0.318–0.762) |
van Zyl [11] | Children <5 years with adult household pulmonary tuberculosis contact (n=181) 2 TB disease; 72 infected; 105 exposed; 2 incompletely evaluated Daily 6H (n=105); 3RH (n=72) | Retrospective study | Completion rate | 66.6% in 3HR; 27.6% in 6H; p<0.0001 | 2.41 (1.70–3.43) |
In children aged <2 years: 43/66 (65.2%) in 3HR; 2/19 (10.5%) in 6H; p<0.0001 | 6.19 (1.65–23.23) |