RESUMEN
PURPOSE: World Health Organization guidelines for antibiotic treatment of trachoma currently include a 6-week course of tetracycline eye ointment twice daily or a single dose of oral azithromycin. Previous trials have shown similar efficacy of these two alternatives when administration of the ointment was carefully supervised. It is believed, however, that azithromycin may be a more effective treatment in practice, and the purpose of this study was to test that hypothesis. METHODS: A masked randomized controlled trial was conducted to compare azithromycin and tetracycline under practical operational conditions-i.e., without supervision of the administration of the ointment. Three hundred fourteen children aged 6 months to 10 years with clinically active trachoma were recruited and individually randomized to receive one of the two treatments. Follow-up visits were conducted at 10 weeks and 6 months. The outcome was resolution of disease (clinical "cure"). RESULTS: Children allocated to azithromycin were significantly more likely to have resolved disease than those allocated to tetracycline, both at 10 weeks (68% versus 51%; cure rate ratio, 1.31; 95% confidence interval [CI], 1.08-1.59; P = 0.007) and at 6 months (88% versus 73%; cure rate ratio, 1.19; 95% CI, 1.06-1.34; P = 0.004). Azithromycin was particularly effective for intense inflammation (P = 0.023, Fisher's exact test). CONCLUSIONS: Single-dose oral azithromycin was a more effective treatment for active trachoma than tetracycline ointment as applied by caregivers. The high cure rate achieved with tetracycline in this study in the absence of supervision and the significantly higher costs of azithromycin, suggest that in the absence of donation programs, switching routine treatment from tetracycline to azithromycin would not be a good use of resources.