Two-Day Dosing versus One-Day Dosing of Azithromycin in Children with Severe Trachoma in Tanzania

Abstract

Purpose: To determine whether 2-day dosing of azithromycin may improve the efficacy of azithromycin dosing in children with severe trachoma.

Methods: Fifty children with severe trachoma (defined as either trachoma intense or follicular trachoma with ten or more follicles) were enrolled from five villages in Kongwa, Tanzania. Enrollment occurred within 1 month and within the same district as the historical control population of 99 children with severe trachoma, all of whom received 1-day dosing. Baseline data on age, sex, and trachoma status were obtained, and swabs for determination of Chlamydia trachomatis were taken. All 50 children received 20 mg/kg azithromycin daily for 2 days, which was directly observed. Children were followed up at 6 weeks for trachoma and infection. The laboratory was masked to treatment assignment.

Results: Baseline characteristics were similar between the treatment group and the control group. A total of 1/46 (2.2%) of children in the treatment group were polymerase chain reaction (PCR)-positive at 6 weeks, a 96.3% reduction from baseline, compared to 13/96 (13.5%) in the historical control group, an 89.4% reduction. This difference was statistically significant. However when modeled using logistic regression and accounting for age, gender, weight, and baseline percent PCR positivity, the difference was not significant. Prevalence of clinical trachoma did not differ between the groups at 6 weeks.

Conclusion: For children with severe trachoma, a randomized controlled trial of 2-day versus 1-day treatment may be warranted.

Keywords::

• Azithromycin
• Trachoma
• Tanzania
• Clinical trial
• Dosing

ACKNOWLEDGMENTS

Financial Support: This study was supported by an unrestricted grant to Sheila West from the Alcon Research Institute. West has a Senior Scientific Investigator award with Research to Prevent Blindness. Pfizer provided azithromycin as part of the overall donation to the Tanzania National Trachoma Control program, but had no role in the design, conduct, analyses, or writing of this manuscript.

Declaration of interest: The authors report no conflict of interest. The authors alone are responsible for the content and writing of the article.