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Sponsors and Collaborators: |
Johns Hopkins University National Eye Institute (NEI) Project ORBIS |
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Information provided by: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT00347776 |
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.
Condition | Intervention | Phase |
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Trichiasis |
Drug: azithromycin |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Trial of Antibiotics to Reduce Recurrent Trichiasis (STAR Trial) |
Estimated Enrollment: | 1450 |
Study Start Date: | August 2001 |
Estimated Study Completion Date: | December 2006 |
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 preventing recurrence of trichiasis following surgery is proposed. This will provide the evidence base to inform and change the global public health policy and the donation program policy, regarding post-surgical treatment for trichiasis patients and possibly their families.
We will determine the impact of three treatment strategies following trichiasis surgery on the rate of trichiasis recurrence in the operated eye at six months and one year. To achieve our objectives, a randomized clinical trial of 1425 trichiasis surgical patients will be conducted in Sodo,Ethiopia. The first group (Control Group) will receive topical tetracycline following surgery; the second group (Intervention Patient Group) will receive oral azithromycin; the third group (Intervention Family Group) will receive oral azithromycin, and all family members resident in the patient’s household will also receive oral azithromycin. Data will be collected at baseline (pre-surgery) on ocular status and infection status. Data will be collected at the time of surgery on surgery-related variables and surgical and post-operative complications. Additional data will be collected on any surgical complications and early recurrence at the two-week visit when sutures will be removed. A follow up visit at two months will include data collection on recurrence and presence of ocular infection. Evaluations for trichiasis recurrence will occur again at six months and at one year post-surgery. The latter visit will also include data collection on presence of ocular infection in the surgical case, and ocular infection in household members. Evaluation of the risk of recurrence at six months and one year within each group will be completed to determine the benefit of using azithromycin compared to topical tetracycline, and the added benefit of family-based treatment.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Maryland | |
Johns Hopkins University | |
Baltimore, Maryland, United States, 21205 |
Principal Investigator: | Sheila K West | Johns Hopkins University |
Study ID Numbers: | U01EY013878 |
Study First Received: | July 3, 2006 |
Last Updated: | July 3, 2006 |
ClinicalTrials.gov Identifier: | NCT00347776 |
Health Authority: | United States: Institutional Review Board; Ethiopia: Ethiopia Science and Technology Commission |
trichiasis azithromycin trichiasis surgery topical tetracycline |
Azithromycin Tetracycline Recurrence |
Anti-Infective Agents Anti-Bacterial Agents Therapeutic Uses Pharmacologic Actions |