Surgery for Trichiasis, Antibiotics to Prevent Recurrence (STAR) Clinical Trial Methodology

Abstract

Trachoma is the leading infectious cause of blindness worldwide. Surgery is available to correct trichiasis, which results from repeated episodes of infection with C. trachomatis. However, trichiasis recurrence rates post-surgery are very high. Methods for reducing post-surgical trichiasis recurrence need to be explored. This paper outlines the design of the Surgery for Trichiasis, Antibiotics to prevent Recurrence (STAR) Clinical Trial currently underway in Ethiopia. The STAR trial, funded by The National Eye Institute, is a randomized, controlled clinical trial of antibiotic use at time of trichiasis surgery, comparing topical tetracycline to single-dose azithromycin for the surgical patient and single-dose azithromycin for the surgical patient and all household members. The primary outcome is trichiasis recurrence at one-year. Data from this trial will be critical in helping to determine future policy on antibiotic treatment for C. trachomatis following surgery.

KEYWORDS:

• Trachoma surgery
• trachoma recurrence
• antibiotic therapy
• tetracycline
• azythromycin
• Chlamydia trachomatis
• STAR Clinical Trial
• trial methodology
• Ethiopia