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.

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01EY013878-03
Application #
6805320
Study Section
Special Emphasis Panel (ZEY1-VSN (02))
Program Officer
Everett, Donald F
Project Start
2002-09-01
Project End
2006-08-31
Budget Start
2004-09-01
Budget End
2005-08-31
Support Year
3
Fiscal Year
2004
Total Cost
$715,406
Indirect Cost
Name
Johns Hopkins University
Department
Ophthalmology
Type
Schools of Medicine
DUNS #
001910777
City
Baltimore
State
MD
Country
United States
Zip Code
21218
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