TRIAL OF ANTIBIOTICS TO REDUCE RECURRENT TRICHIASIS

Johns Hopkins University, Baltimore MD

Investigators

Linked publications & trials

Abstract

Trachoma, caused by C. trachomatis, is the second leading cause of blindness worldwide, and control is a top priority of the blindness prevention community. In trachoma-endemic areas, 10% or more of adults have trichiasis, resulting from years of repeated infection, which is high risk for subsequent visual loss. Trichiasis can be corrected with surgery, but the recurrence rate at one year is disappointingly high, 17%, and it increases in subsequent years. There is strong evidence that ongoing exposure to infection with C. trachomatis, either from a persistent injection or exposure within families, drives ongoing scarring and trichiasis in these cases. The primary questions to be addressed by this investigation are: 1) Does post-surgical treatment of trichiasis cases with azithromycin reduce the one-year recurrence rate of trichiasis compared to standard care (topical tetracycline)? 2) Does post-surgical treatment of cases plus household members with azithromycin reduce the one-year recurrence rate of trichiasis compared to standard treatment? We propose a randomized, controlled clinical trial of 1425 adults with trichiasis scheduled for surgery in two health centers in the Lanfuro district of Ethiopia to address this questions. The three arm trial will have one arm in which cases receive a single dose of azithromycin post- surgery; a third arm in which cases will receive topical tetracycline post- surgery. Data on other risk factors will include baseline severity of trichiasis, surgery-related factors, and laboratory evidence and re- infection. Cases will be examined at 2 weeks and 2, 6, and 12 months post-surgery for recurrence of trichiasis. The results of this trial will have immediate public health impact by providing information for WHO recommendations for post-surgical treatment of trichiasis, as well as by guiding policy on azithromycin use for the 22 countries beginning National Trachoma Control programs worldwide.