Study of Azithromycin to Prevent Recurrent Trichiasis Following Surgery in Ethiopia

Trichiasis Clinical Trial

— STAR  

Official title:

Trial of Antibiotics to Reduce Recurrent Trichiasis (STAR)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00347776
• Other study ID #: U01EY013878
• Status: Completed
• Phase: Phase 4
• First received: July 3, 2006
• Last updated: April 3, 2013
• Start date: August 2001
• Est. completion date: December 2006

Study information

• Verified date: April 2013
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardEthiopia: Ethiopia Science and Technology Commission
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1450
• Est. completion date: December 2006
• Est. primary completion date: December 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Trichiasis

Intervention

Drug:
• azithromycin
oral antibiotic
• topical tetracycline

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins University	National Eye Institute (NEI), Project ORBIS

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrent trichiasis	clinical assessment of one or more eyelashes touching globe	1, 2, and 3-year follow-up	No
Secondary	surgical failure	clinical measure of one or more eyelashes touching globe	2 weeks	No
Secondary	adverse events	any report of hospitalization, death, or clinic visit within four weeks of receiving surgery	4 weeks	Yes