Study of Azithromycin to Prevent Recurrent Trichiasis Following Surgery in Ethiopia (STAR)

• Sponsor: Johns Hopkins University
• Collaborators: National Eye Institute (NEI); Project ORBIS
• Information provided by (Responsible Party): Johns Hopkins University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Trichiasis	Drug: azithromycin; Drug: topical tetracycline	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1452 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Trial of Antibiotics to Reduce Recurrent Trichiasis (STAR)
• Study Start Date: August 2001
• Actual Primary Completion Date: December 2003
• Actual Study Completion Date: December 2006

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Control; topical tetracycline	Drug: topical tetracycline
Active Comparator: Intervention 1; oral azithromycin, single 1g dose to subject	Drug: azithromycin; oral antibiotic; Other Name: Zithromax
Active Comparator: Intervention 2; single oral azithromycin dose to subject and immediate family members	Drug: azithromycin; oral antibiotic; Other Name: Zithromax

Outcome Measures

Primary Outcome Measures :

1. Recurrent Trichiasis in Tetracycline and Azithromycin Groups [ Time Frame: 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.
2. Recurrent Trichiasis Between Two Azithromycin Arms [ Time Frame: 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 :

1. Surgical Failure [ Time Frame: 6 weeks ]
   The surgery was considered a failure if one or more eye lashes were touching the globe of the eye of the subject.
2. Adverse Events [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Maryland

Johns Hopkins University

Baltimore, Maryland, United States, 21205

Sponsors and Collaborators

Johns Hopkins University

National Eye Institute (NEI)

Project ORBIS

Investigators

• Principal Investigator: Sheila K West; Johns Hopkins University

More Information

Publications of Results:

West SK, West ES, Alemayehu W, Melese M, Munoz B, Imeru A, Worku A, Gaydos C, Meinert CL, Quinn T. Single-dose azithromycin prevents trichiasis recurrence following surgery: randomized trial in Ethiopia. Arch Ophthalmol. 2006 Mar;124(3):309-14.

Other Publications:

Melese M, West ES, Alemayehu W, Munoz B, Worku A, Gaydos CA, West SK. Characteristics of trichiasis patients presenting for surgery in rural Ethiopia. Br J Ophthalmol. 2005 Sep;89(9):1084-8.

West ES, Munoz B, Imeru A, Alemayehu W, Melese M, West SK. The association between epilation and corneal opacity among eyes with trachomatous trichiasis. Br J Ophthalmol. 2006 Feb;90(2):171-4.

West ES, Alemayehu W, Munoz B, Melese M, Imeru A, West SK. Surgery for Trichiasis, Antibiotics to prevent Recurrence (STAR) Clinical Trial methodology. Ophthalmic Epidemiol. 2005 Aug;12(4):279-86.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Woreta F, Munoz B, Gower E, Alemayehu W, West SK. Three-year outcomes of the surgery for trichiasis, antibiotics to prevent recurrence trial. Arch Ophthalmol. 2012 Apr;130(4):427-31. doi: 10.1001/archophthalmol.2011.374. Epub 2011 Dec 12.

Gower EW, Merbs SL, Munoz BE, Kello AB, Alemayehu W, Imeru A, West SK. Rates and risk factors for unfavorable outcomes 6 weeks after trichiasis surgery. Invest Ophthalmol Vis Sci. 2011 Apr 25;52(5):2704-11. doi: 10.1167/iovs.10-5161. Print 2011 Apr.

Woreta TA, Munoz BE, Gower EW, Alemayehu W, West SK. Effect of trichiasis surgery on visual acuity outcomes in Ethiopia. Arch Ophthalmol. 2009 Nov;127(11):1505-10. doi: 10.1001/archophthalmol.2009.278.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT00347776 History of Changes
• Other Study ID Numbers: U01EY013878 ( U.S. NIH Grant/Contract )
• First Posted: July 4, 2006
• Results First Posted: August 7, 2017
• Last Update Posted: August 7, 2017
• Last Verified: June 2017

Keywords provided by Johns Hopkins University:

trichiasis; azithromycin; trichiasis surgery; topical tetracycline

Additional relevant MeSH terms:

Trichiasis; Eyelid Diseases; Eye Diseases; Tetracycline; Anti-Bacterial Agents; Anti-Infective Agents; Protein Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action