drugset / Trial / NCT00347776

Study of Azithromycin to Prevent Recurrent Trichiasis Following Surgery in Ethiopia

NCT00347776

RandomizedParallel-groupSingle-blindPrevention

Summary

Trachoma, an ocular infection caused by C. trachomatis, is the second leading cause of blindness worldwide.Years of repeated infection with C. trachomatis cause the eyelid to scar and contract and ultimately to rotate inward such that eyelashes rub against the eyeball and abrade the cornea (trichiasis). The World Health Organization (WHO) has endorsed a multi-faceted strategy to combat trachoma, which includes surgery to correct trichiasis. Despite this encouraging news, under the best of circumstances the recurrence rate of trichiasis following surgery is disappointingly high. The objective of our project is to conduct a randomized, controlled clinical trial of post-surgical antibiotic treatment, comparing oral azithromycin to topical tetracycline, for trichiasis surgical patients in Ethiopia with the goal of determining the impact of treatment on rates of trichiasis recurrence at one and two years.

Timeline

Start
2001-08
Primary completion
2003-12
Completion
2006-12

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Azithromycin Small molecule 20 mg/kg Oral
Comparator Azithromycin Small molecule 1 g Oral
Comparator topical tetracycline Unknown Topical

Indications