Overview

Study of Azithromycin to Prevent Recurrent Trichiasis Following Surgery in Ethiopia

Status:
Completed
Trial end date:
2006-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Johns Hopkins University
Collaborators:
National Eye Institute (NEI)
Project ORBIS
Treatments:
Azithromycin
Tetracycline
Criteria
Inclusion Criteria:

- Presence of trichiasis:

- no previous report of trichiasis surgery in at least one eye with trichiasis:

- Agreement by at least one other family member accompanying the patient that, if the
patient is randomized to the family-treatment arm, s/he also would be willing to
receive antibiotic treatment

- Age 18 or older

Exclusion Criteria:

- other household members concurrently participating in the trial

- Self-reported pregnancy

- Documented allergy to tetracycline

- Plans to move out of the region within 1 year.