Operational comparison of single-dose azithromycin and topical tetracycline for trachoma

PURPOSE. World Health Organization guidelines for antibiotic treatment of t rachoma currently include a 6-week course of tetracycline eye ointment twic e daily or a single dose of oral azithromycin. Previous trials have shown s imilar efficacy of these two alternatives when administration of the ointme nt was carefully supervised. It is believed, however, that azithromycin may be a more effective treatment in practice, and the purpose of this study w as to test that hypothesis. METHODS. A masked randomized controlled trial was conducted to compare azit hromycin and tetracycline under practical operational conditions-i.e., with out supervision of the administration of the ointment. Three hundred fourte en 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 w eeks (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, 1.1 9; 95% CI, 1.06-1.34; P = 0.004). Azithromycin was particularly effective f or intense inflammation (P = 0.023, Fisher's exact test). CONCLUSIONS. Single-dose oral azithromycin was a more effective treatment f or 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 tha t in the absence of donation programs, switching routine treatment from tet racycline to azithromycin would not be a good use of resources.