Study of Azithromycin to Prevent Recurrent Trichiasis Following Surgery in Ethiopia
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
- Background Melese M, West ES, Alemayehu W, Munoz B, Worku A, Gaydos CA, West SK. Characteristics of trichiasis patients presenting for surgery in rural Ethiopia. Br J Ophthalmol. 2005 Sep;89(9):1084-8. doi: 10.1136/bjo.2005.066076.
- Background West ES, Munoz B, Imeru A, Alemayehu W, Melese M, West SK. The association between epilation and corneal opacity among eyes with trachomatous trichiasis. Br J Ophthalmol. 2006 Feb;90(2):171-4. doi: 10.1136/bjo.2005.075390.
- Background West ES, Alemayehu W, Munoz B, Melese M, Imeru A, West SK. Surgery for Trichiasis, Antibiotics to prevent Recurrence (STAR) Clinical Trial methodology. Ophthalmic Epidemiol. 2005 Aug;12(4):279-86. doi: 10.1080/09286580591005769.
- Results West SK, West ES, Alemayehu W, Melese M, Munoz B, Imeru A, Worku A, Gaydos C, Meinert CL, Quinn T. Single-dose azithromycin prevents trichiasis recurrence following surgery: randomized trial in Ethiopia. Arch Ophthalmol. 2006 Mar;124(3):309-14. doi: 10.1001/archopht.124.3.309.
- Woreta F, Munoz B, Gower E, Alemayehu W, West SK. Three-year outcomes of the surgery for trichiasis, antibiotics to prevent recurrence trial. Arch Ophthalmol. 2012 Apr;130(4):427-31. doi: 10.1001/archophthalmol.2011.374. Epub 2011 Dec 12.
- Gower EW, Merbs SL, Munoz BE, Kello AB, Alemayehu W, Imeru A, West SK. Rates and risk factors for unfavorable outcomes 6 weeks after trichiasis surgery. Invest Ophthalmol Vis Sci. 2011 Apr 25;52(5):2704-11. doi: 10.1167/iovs.10-5161. Print 2011 Apr.
- Woreta TA, Munoz BE, Gower EW, Alemayehu W, West SK. Effect of trichiasis surgery on visual acuity outcomes in Ethiopia. Arch Ophthalmol. 2009 Nov;127(11):1505-10. doi: 10.1001/archophthalmol.2009.278.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Azithromycin | Small molecule | 20 mg/kg | Oral |
| Comparator | Azithromycin | Small molecule | 1 g | Oral |
| Comparator | topical tetracycline | Unknown | — | Topical |