Study of Azithromycin to Prevent Recurrent Trichiasis Following Surgery in Ethiopia

Phase 4

Completed

Conditions: Trichiasis

Interventions: Drug: topical tetracycline
Drug: azithromycin

Registration Number: NCT00347776

Lead Sponsor: Johns Hopkins University

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 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1452

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	topical tetracycline	topical tetracycline
Intervention 1	azithromycin	oral azithromycin, single 1g dose to subject
Intervention 2	azithromycin	single oral azithromycin dose to subject and immediate family members

Primary Outcome Measures

Name	Time	Method
Recurrent Trichiasis in Tetracycline and Azithromycin Groups	Primary outcome assessed at 2 weeks,1.5 months, 6 months and 12 months post-surgery	Recurrence of trichiasis : Clinical assessment was done by looking for one or more eye lashes touching globe or evidence of epilation.
Recurrent Trichiasis Between Two Azithromycin Arms	Primary outcome assessed at 2 weeks,1.5 months, 6 months and 12 months post-surgery	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.

Secondary Outcome Measures

Name	Time	Method
Surgical Failure	6 weeks	The surgery was considered a failure if one or more eye lashes were touching the globe of the eye of the subject.
Adverse Events	6 weeks	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.