Study of Azithromycin to Prevent Recurrent Trichiasis Following Surgery in Ethiopia

Study Overview
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Brief Summary
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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.

Detailed Description
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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. The investigators 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. 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, two, and three years 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.

Official Title
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Trial of Antibiotics to Reduce Recurrent Trichiasis (STAR)

Conditions
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Trichiasis

Intervention / Treatment
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* Drug: azithromycin
* Drug: topical tetracycline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>topical tetracycline | Drug: topical tetracycline<br> <br> |
| Active Comparator: Intervention 1<br>oral azithromycin, single 1g dose to subject | Drug: azithromycin<br>* oral antibiotic<br>* Other names: Zithromax;|
| Active Comparator: Intervention 2<br>single oral azithromycin dose to subject and immediate family members | Drug: azithromycin<br>* oral antibiotic<br>* Other names: Zithromax;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent Trichiasis in Tetracycline and Azithromycin Groups | Recurrence of trichiasis : Clinical assessment was done by looking for one or more eye lashes touching globe or evidence of epilation. | Primary outcome assessed at 2 weeks,1.5 months, 6 months and 12 months post-surgery | 
| Recurrent Trichiasis Between Two Azithromycin Arms | Recurrence of trichiasis :Clinical assessment for recurrence was done by looking for one or more eye lashes touching globe or evidence of epilation. If there was evidence of epilation or if one or more eye lashes were touching the globe, it was considered as recurrence of trichiasis. | Primary outcome assessed at 2 weeks,1.5 months, 6 months and 12 months post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical Failure | The surgery was considered a failure if one or more eye lashes were touching the globe of the eye of the subject. | 6 weeks | 
| Adverse Events | At 6 weeks participants/family members were asked about any hospitalization,death,ocular complaints, gastrointestinal illness or other specific illness or any clinic visit within six weeks of receiving surgery. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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azithromycin, trichiasis, trichiasis surgery, topical tetracycline