Status:
COMPLETED
Study of Azithromycin to Prevent Recurrent Trichiasis Following Surgery in Ethiopia
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Eye Institute (NEI)
Project ORBIS
Conditions:
Trichiasis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ult...
Detailed Description
A randomized clinical trial of the effectiveness of a single dose of azithromycin compared to 6 weeks of topical tetracycline, and the added benefit of family-based azithromycin treatment, in preventi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
1452 Patients enrolled
Trial Details
Trial ID
NCT00347776
Start Date
August 1 2001
End Date
December 1 2006
Last Update
August 7 2017
Active Locations (1)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21205